Study of the Effectiveness of Additional Reductions of Cholesterol and Homocysteine (SEARCH)

Serious adverse events by MedDRA classification

These results are organised hierarchically by MedDRA SOC, HLGT and HLT categories. To expand a row to show the next level of the hierarchy, click the + symbol; to contract it, click the - symbol.

Simvastatin comparison: Fatal or non-fatal serious adverse events in all patients

	MedDRA term	Simvastatin 80mg		Simvastatin 20mg		Risk ratio (95% CI)		Absolute excess (SE)
	Any event	5023	(83.3%)	5039	(83.5%)	1.00	(0.96- 1.04)	-0.24%	( 0.68%)
	Blood and lymphatic system disorders	116	( 1.9%)	121	( 2.0%)	0.96	(0.74- 1.24)	-0.08%	( 0.25%)
	Anaemias nonhaemolytic and marrow depression	80	( 1.3%)	99	( 1.6%)	0.81	(0.60- 1.08)	-0.31%	( 0.22%)
	Anaemia deficiencies	33	( 0.5%)	37	( 0.6%)	0.89	(0.56- 1.43)	-0.07%	( 0.14%)
	Anaemias NEC	48	( 0.8%)	63	( 1.0%)	0.76	(0.53- 1.11)	-0.25%	( 0.17%)
	Haematological disorders NEC	3	( 0.0%)	1	( 0.0%)	2.71	(0.38- 19.24)	0.03%	( 0.03%)
	Haematological disorders	3	( 0.0%)	1	( 0.0%)	2.71	(0.38- 19.24)	0.03%	( 0.03%)
	Platelet disorders	13	( 0.2%)	5	( 0.1%)	2.43	(0.97- 6.13)	0.13%	( 0.07%)
	Platelet disorders NEC	7	( 0.1%)	2	( 0.0%)	3.04	(0.82- 11.22)	0.08%	( 0.05%)
	Thrombocytopenias	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.67)	0.03%	( 0.04%)
	Thrombocytoses	3	( 0.0%)	2	( 0.0%)	1.48	(0.26- 8.57)	0.02%	( 0.04%)
	Red blood cell disorders	5	( 0.1%)	6	( 0.1%)	0.83	(0.26- 2.72)	-0.02%	( 0.05%)
	Polycythaemia (excl rubra vera)	5	( 0.1%)	6	( 0.1%)	0.83	(0.26- 2.72)	-0.02%	( 0.05%)
	Spleen, lymphatic and reticuloendothelial system disorders	4	( 0.1%)	0	( 0.0%)	7.39	(1.04- 52.49)	0.07%	( 0.03%)
	Lymphatic system disorders NEC	4	( 0.1%)	0	( 0.0%)	7.39	(1.04- 52.49)	0.07%	( 0.03%)
	White blood cell disorders	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.62)	-0.03%	( 0.03%)
	Neutropenias	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.62)	-0.03%	( 0.03%)
	Coagulopathies and bleeding diatheses (excl thrombocytopenic)	15	( 0.2%)	10	( 0.2%)	1.49	(0.68- 3.27)	0.08%	( 0.08%)
	Coagulopathies	15	( 0.2%)	10	( 0.2%)	1.49	(0.68- 3.27)	0.08%	( 0.08%)
	Cardiac disorders	1722	(28.6%)	1747	(29.0%)	0.98	(0.92- 1.05)	-0.40%	( 0.82%)
	Cardiac arrhythmias	319	( 5.3%)	343	( 5.7%)	0.93	(0.80- 1.08)	-0.40%	( 0.41%)
	Cardiac conduction disorders	1	( 0.0%)	10	( 0.2%)	0.19	(0.06- 0.63)	-0.15%	( 0.05%)
	Rate and rhythm disorders NEC	138	( 2.3%)	124	( 2.1%)	1.11	(0.87- 1.42)	0.23%	( 0.27%)
	Supraventricular arrhythmias	194	( 3.2%)	196	( 3.2%)	0.99	(0.81- 1.21)	-0.03%	( 0.32%)
	Ventricular arrhythmias and cardiac arrest	19	( 0.3%)	32	( 0.5%)	0.60	(0.35- 1.04)	-0.22%	( 0.12%)
	Cardiac disorder signs and symptoms	49	( 0.8%)	46	( 0.8%)	1.07	(0.71- 1.59)	0.05%	( 0.16%)
	Cardiac disorders NEC	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Cardiac signs and symptoms NEC	47	( 0.8%)	44	( 0.7%)	1.07	(0.71- 1.61)	0.05%	( 0.16%)
	Coronary artery disorders	1173	(19.4%)	1218	(20.2%)	0.96	(0.89- 1.04)	-0.74%	( 0.73%)
	Coronary artery disorders NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.88)	-0.02%	( 0.04%)
	Ischaemic coronary artery disorders	1171	(19.4%)	1216	(20.2%)	0.96	(0.89- 1.04)	-0.74%	( 0.73%)
	Heart failures	254	( 4.2%)	254	( 4.2%)	1.00	(0.84- 1.19)	0.00%	( 0.37%)
	Heart failures NEC	244	( 4.0%)	244	( 4.0%)	1.00	(0.84- 1.19)	0.00%	( 0.36%)
	Left ventricular failures	12	( 0.2%)	14	( 0.2%)	0.86	(0.40- 1.85)	-0.03%	( 0.08%)
	Right ventricular failures	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.41)	0.02%	( 0.02%)
	Myocardial disorders	217	( 3.6%)	193	( 3.2%)	1.12	(0.93- 1.37)	0.40%	( 0.33%)
	Cardiomyopathies	216	( 3.6%)	190	( 3.1%)	1.14	(0.94- 1.38)	0.43%	( 0.33%)
	Myocardial disorders NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.99)	0.00%	( 0.02%)
	Noninfectious myocarditis	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Pericardial disorders	4	( 0.1%)	4	( 0.1%)	1.00	(0.25- 4.00)	0.00%	( 0.05%)
	Pericardial disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Noninfectious pericarditis	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.86)	0.02%	( 0.04%)
	Cardiac valve disorders	15	( 0.2%)	7	( 0.1%)	2.08	(0.90- 4.79)	0.13%	( 0.08%)
	Aortic valvular disorders	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.86)	0.02%	( 0.03%)
	Mitral valvular disorders	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.95)	-0.02%	( 0.03%)
	Cardiac valve disorders NEC	12	( 0.2%)	4	( 0.1%)	2.72	(1.02- 7.25)	0.13%	( 0.07%)
	Congenital, familial and genetic disorders	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.55)	-0.03%	( 0.04%)
	Blood and lymphatic system disorders congenital	1	( 0.0%)	0	( 0.0%)	7.37	(0.15-371.41)	0.02%	( 0.02%)
	Haemoglobinopathies congenital	1	( 0.0%)	0	( 0.0%)	7.37	(0.15-371.41)	0.02%	( 0.02%)
	Metabolic and nutritional disorders congenital	0	( 0.0%)	4	( 0.1%)	0.14	(0.02- 0.96)	-0.07%	( 0.03%)
	Inborn errors of bilirubin metabolism	0	( 0.0%)	4	( 0.1%)	0.14	(0.02- 0.96)	-0.07%	( 0.03%)
	Reproductive tract and breast disorders congenital	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.23)	0.02%	( 0.02%)
	Male reproductive tract disorders congenital	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.23)	0.02%	( 0.02%)
	Ear and labyrinth disorders	41	( 0.7%)	43	( 0.7%)	0.95	(0.62- 1.46)	-0.03%	( 0.15%)
	Hearing disorders	9	( 0.1%)	10	( 0.2%)	0.90	(0.37- 2.22)	-0.02%	( 0.07%)
	Hearing losses	9	( 0.1%)	10	( 0.2%)	0.90	(0.37- 2.22)	-0.02%	( 0.07%)
	Inner ear and VIIIth cranial nerve disorders	29	( 0.5%)	33	( 0.5%)	0.88	(0.53- 1.45)	-0.07%	( 0.13%)
	Inner ear signs and symptoms	26	( 0.4%)	32	( 0.5%)	0.81	(0.49- 1.36)	-0.10%	( 0.13%)
	Inner ear disorders NEC	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.97)	0.00%	( 0.04%)
	Aural disorders NEC	3	( 0.0%)	0	( 0.0%)	7.39	(0.77- 71.05)	0.05%	( 0.03%)
	Ear disorders NEC	3	( 0.0%)	0	( 0.0%)	7.39	(0.77- 71.05)	0.05%	( 0.03%)
	Endocrine disorders	77	( 1.3%)	92	( 1.5%)	0.84	(0.62- 1.13)	-0.25%	( 0.21%)
	Adrenal gland disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Adrenal cortical hyperfunctions	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Thyroid gland disorders	76	( 1.3%)	91	( 1.5%)	0.83	(0.62- 1.13)	-0.25%	( 0.21%)
	Thyroid disorders NEC	12	( 0.2%)	11	( 0.2%)	1.09	(0.48- 2.47)	0.02%	( 0.08%)
	Thyroid hyperfunction disorders	23	( 0.4%)	11	( 0.2%)	2.03	(1.04- 3.97)	0.20%	( 0.10%)
	Thyroid hypofunction disorders	46	( 0.8%)	71	( 1.2%)	0.65	(0.45- 0.94)	-0.41%	( 0.18%)
	Endocrine and glandular disorders NEC	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.39)	0.02%	( 0.02%)
	Endocrine disorders NEC	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.39)	0.02%	( 0.02%)
	Eye disorders	127	( 2.1%)	133	( 2.2%)	0.95	(0.75- 1.22)	-0.10%	( 0.26%)
	Eye disorders NEC	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Corneal disorders NEC	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Ocular disorders NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Ocular infections, irritations and inflammations	3	( 0.0%)	2	( 0.0%)	1.49	(0.26- 8.62)	0.02%	( 0.04%)
	Iris and uveal tract infections, irritations and inflammations	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.51)	0.03%	( 0.02%)
	Ocular infections, inflammations and associated manifestations	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.97)	0.00%	( 0.02%)
	Retinal, choroid and vitreous infections and inflammations	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Ocular structural change, deposit and degeneration NEC	35	( 0.6%)	33	( 0.5%)	1.06	(0.66- 1.71)	0.03%	( 0.14%)
	Retinal structural change, deposit and degeneration	35	( 0.6%)	33	( 0.5%)	1.06	(0.66- 1.71)	0.03%	( 0.14%)
	Retina, choroid and vitreous haemorrhages and vascular disorders	27	( 0.4%)	36	( 0.6%)	0.75	(0.46- 1.23)	-0.15%	( 0.13%)
	Retinal bleeding and vascular disorders (excl retinopathy)	10	( 0.2%)	17	( 0.3%)	0.59	(0.28- 1.26)	-0.12%	( 0.09%)
	Retinopathies NEC	19	( 0.3%)	22	( 0.4%)	0.86	(0.47- 1.59)	-0.05%	( 0.11%)
	Vision disorders	68	( 1.1%)	63	( 1.0%)	1.08	(0.77- 1.52)	0.08%	( 0.19%)
	Blindness (excl colour blindness)	15	( 0.2%)	16	( 0.3%)	0.94	(0.46- 1.90)	-0.02%	( 0.09%)
	Visual disorders NEC	54	( 0.9%)	49	( 0.8%)	1.10	(0.75- 1.62)	0.08%	( 0.17%)
	Gastrointestinal disorders	510	( 8.5%)	567	( 9.4%)	0.89	(0.79- 1.01)	-0.94%	( 0.52%)
	Abdominal hernias and other abdominal wall conditions	32	( 0.5%)	45	( 0.7%)	0.71	(0.46- 1.11)	-0.22%	( 0.14%)
	Abdominal hernias, site unspecified	7	( 0.1%)	8	( 0.1%)	0.88	(0.32- 2.41)	-0.02%	( 0.06%)
	Diaphragmatic hernias	26	( 0.4%)	37	( 0.6%)	0.70	(0.43- 1.15)	-0.18%	( 0.13%)
	Anal and rectal conditions NEC	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.96)	-0.02%	( 0.05%)
	Anal and rectal disorders NEC	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.96)	-0.02%	( 0.05%)
	Diverticular disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.88)	-0.02%	( 0.02%)
	Diverticula	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.88)	-0.02%	( 0.02%)
	Exocrine pancreas conditions	19	( 0.3%)	33	( 0.5%)	0.58	(0.34- 1.00)	-0.23%	( 0.12%)
	Pancreatic disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Acute and chronic pancreatitis	19	( 0.3%)	32	( 0.5%)	0.60	(0.35- 1.04)	-0.22%	( 0.12%)
	Gastrointestinal conditions NEC	92	( 1.5%)	117	( 1.9%)	0.79	(0.60- 1.03)	-0.41%	( 0.24%)
	Gastrointestinal disorders NEC	82	( 1.4%)	102	( 1.7%)	0.80	(0.60- 1.07)	-0.33%	( 0.22%)
	Gastrointestinal fistulae	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-372.94)	0.02%	( 0.02%)
	Oesophageal disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Gastrointestinal mucosal dystrophies and secretion disorders	10	( 0.2%)	14	( 0.2%)	0.72	(0.32- 1.59)	-0.07%	( 0.08%)
	Gastrointestinal haemorrhages NEC	95	( 1.6%)	116	( 1.9%)	0.82	(0.62- 1.07)	-0.35%	( 0.24%)
	Non-site specific gastrointestinal haemorrhages	66	( 1.1%)	79	( 1.3%)	0.83	(0.60- 1.16)	-0.22%	( 0.20%)
	Intestinal haemorrhages	29	( 0.5%)	38	( 0.6%)	0.76	(0.47- 1.23)	-0.15%	( 0.14%)
	Gastrointestinal inflammatory conditions	51	( 0.8%)	53	( 0.9%)	0.96	(0.65- 1.41)	-0.03%	( 0.17%)
	Colitis (excl infective)	25	( 0.4%)	28	( 0.5%)	0.89	(0.52- 1.53)	-0.05%	( 0.12%)
	Gastritis (excl infective)	22	( 0.4%)	23	( 0.4%)	0.96	(0.53- 1.72)	-0.02%	( 0.11%)
	Gastrointestinal inflammatory disorders NEC	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.65)	0.03%	( 0.04%)
	Gastrointestinal motility and defaecation conditions	55	( 0.9%)	51	( 0.8%)	1.08	(0.74- 1.58)	0.07%	( 0.17%)
	Diarrhoea (excl infective)	23	( 0.4%)	29	( 0.5%)	0.79	(0.46- 1.37)	-0.10%	( 0.12%)
	Gastrointestinal atonic and hypomotility disorders NEC	27	( 0.4%)	17	( 0.3%)	1.58	(0.87- 2.85)	0.17%	( 0.11%)
	Gastrointestinal dyskinetic disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Gastrointestinal spastic and hypermotility disorders	4	( 0.1%)	4	( 0.1%)	1.00	(0.25- 4.00)	0.00%	( 0.05%)
	Non-mechanical ileus	1	( 0.0%)	0	( 0.0%)	7.24	(0.14-365.20)	0.02%	( 0.02%)
	Gastrointestinal stenosis and obstruction	11	( 0.2%)	12	( 0.2%)	0.92	(0.40- 2.07)	-0.02%	( 0.08%)
	Gastrointestinal stenosis and obstruction NEC	10	( 0.2%)	9	( 0.1%)	1.11	(0.45- 2.73)	0.02%	( 0.07%)
	Oesophageal stenosis and obstruction	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.62)	-0.03%	( 0.03%)
	Gastrointestinal signs and symptoms	153	( 2.5%)	148	( 2.5%)	1.03	(0.82- 1.30)	0.08%	( 0.28%)
	Dyspeptic signs and symptoms	31	( 0.5%)	37	( 0.6%)	0.84	(0.52- 1.35)	-0.10%	( 0.14%)
	Flatulence, bloating and distension	2	( 0.0%)	0	( 0.0%)	7.35	(0.46-117.47)	0.03%	( 0.02%)
	Gastrointestinal and abdominal pains (excl oral and throat)	83	( 1.4%)	81	( 1.3%)	1.03	(0.76- 1.39)	0.03%	( 0.21%)
	Gastrointestinal signs and symptoms NEC	17	( 0.3%)	15	( 0.2%)	1.13	(0.57- 2.27)	0.03%	( 0.09%)
	Nausea and vomiting symptoms	25	( 0.4%)	19	( 0.3%)	1.31	(0.73- 2.37)	0.10%	( 0.11%)
	Gastrointestinal ulceration and perforation	38	( 0.6%)	44	( 0.7%)	0.86	(0.56- 1.33)	-0.10%	( 0.15%)
	Duodenal ulcers and perforation	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.61)	-0.03%	( 0.03%)
	Gastric ulcers and perforation	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.01)	0.00%	( 0.02%)
	Gastrointestinal ulcers and perforation, site unspecified	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.75)	0.02%	( 0.03%)
	Oesophageal ulcers and perforation	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Intestinal ulcers and perforation NEC	2	( 0.0%)	5	( 0.1%)	0.42	(0.10- 1.86)	-0.05%	( 0.04%)
	Peptic ulcers and perforation	32	( 0.5%)	34	( 0.6%)	0.94	(0.58- 1.53)	-0.03%	( 0.13%)
	Gastrointestinal vascular conditions	6	( 0.1%)	6	( 0.1%)	1.01	(0.32- 3.12)	0.00%	( 0.06%)
	Gastrointestinal vascular occlusion and infarction	2	( 0.0%)	4	( 0.1%)	0.52	(0.10- 2.57)	-0.03%	( 0.04%)
	Haemorrhoids and gastrointestinal varices (excl oesophageal)	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.09)	0.03%	( 0.02%)
	Oesophageal varices	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Malabsorption conditions	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Malabsorption syndromes	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Oral soft tissue conditions	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Stomatitis and ulceration	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Peritoneal and retroperitoneal conditions	3	( 0.0%)	8	( 0.1%)	0.40	(0.12- 1.31)	-0.08%	( 0.05%)
	Peritoneal and retroperitoneal disorders	2	( 0.0%)	7	( 0.1%)	0.33	(0.09- 1.21)	-0.08%	( 0.05%)
	Peritoneal and retroperitoneal fibrosis and adhesions	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	0.00%	( 0.02%)
	Dental and gingival conditions	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Dental disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	General disorders and administration site conditions	484	( 8.0%)	450	( 7.5%)	1.08	(0.95- 1.23)	0.57%	( 0.49%)
	Body temperature conditions	5	( 0.1%)	2	( 0.0%)	2.36	(0.54- 10.37)	0.05%	( 0.04%)
	Febrile disorders	5	( 0.1%)	2	( 0.0%)	2.36	(0.54- 10.37)	0.05%	( 0.04%)
	Tissue disorders NEC	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.98)	0.02%	( 0.02%)
	Mass conditions NEC	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.98)	0.02%	( 0.02%)
	General system disorders NEC	470	( 7.8%)	440	( 7.3%)	1.07	(0.94- 1.22)	0.50%	( 0.48%)
	Asthenic conditions	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.86)	0.02%	( 0.04%)
	General signs and symptoms NEC	95	( 1.6%)	81	( 1.3%)	1.17	(0.87- 1.58)	0.23%	( 0.22%)
	Hernias NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Oedema NEC	41	( 0.7%)	48	( 0.8%)	0.85	(0.56- 1.29)	-0.12%	( 0.16%)
	Pain and discomfort NEC	348	( 5.8%)	330	( 5.5%)	1.06	(0.91- 1.23)	0.30%	( 0.42%)
	Therapeutic and nontherapeutic effects (excl toxicity)	8	( 0.1%)	10	( 0.2%)	0.80	(0.32- 2.02)	-0.03%	( 0.07%)
	Therapeutic and nontherapeutic responses	8	( 0.1%)	10	( 0.2%)	0.80	(0.32- 2.02)	-0.03%	( 0.07%)
	Hepatobiliary disorders	107	( 1.8%)	95	( 1.6%)	1.13	(0.85- 1.48)	0.20%	( 0.23%)
	Bile duct disorders	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.97)	0.00%	( 0.04%)
	Bile duct infections and inflammations	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.74)	0.02%	( 0.03%)
	Obstructive bile duct disorders (excl neoplasms)	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.26)	0.02%	( 0.02%)
	Structural and other bile duct disorders	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Gallbladder disorders	89	( 1.5%)	83	( 1.4%)	1.07	(0.79- 1.44)	0.10%	( 0.22%)
	Cholecystitis and cholelithiasis	88	( 1.5%)	82	( 1.4%)	1.07	(0.79- 1.45)	0.10%	( 0.21%)
	Gallbladder disorders NEC	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.81)	0.02%	( 0.03%)
	Hepatic and hepatobiliary disorders	19	( 0.3%)	15	( 0.2%)	1.27	(0.65- 2.48)	0.07%	( 0.10%)
	Cholestasis and jaundice	7	( 0.1%)	5	( 0.1%)	1.40	(0.45- 4.33)	0.03%	( 0.06%)
	Hepatic fibrosis and cirrhosis	5	( 0.1%)	2	( 0.0%)	2.37	(0.54- 10.41)	0.05%	( 0.04%)
	Hepatocellular damage and hepatitis NEC	5	( 0.1%)	4	( 0.1%)	1.25	(0.34- 4.61)	0.02%	( 0.05%)
	Hepatic and hepatobiliary disorders NEC	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.31)	-0.02%	( 0.04%)
	Immune system disorders	20	( 0.3%)	20	( 0.3%)	1.00	(0.54- 1.86)	0.00%	( 0.10%)
	Allergic conditions	16	( 0.3%)	17	( 0.3%)	0.94	(0.48- 1.86)	-0.02%	( 0.10%)
	Allergies to foods, food additives, drugs and other chemicals	6	( 0.1%)	7	( 0.1%)	0.86	(0.29- 2.54)	-0.02%	( 0.06%)
	Anaphylactic responses	5	( 0.1%)	7	( 0.1%)	0.72	(0.23- 2.22)	-0.03%	( 0.06%)
	Allergic conditions NEC	6	( 0.1%)	3	( 0.0%)	1.95	(0.53- 7.19)	0.05%	( 0.05%)
	Immune disorders NEC	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Amyloidoses	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Immune and associated conditions NEC	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.57)	0.02%	( 0.02%)
	Acute and chronic sarcoidosis	3	( 0.0%)	0	( 0.0%)	7.40	(0.77- 71.18)	0.05%	( 0.03%)
	Vasculitides	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Transplant rejections	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Infections and infestations	850	(14.1%)	866	(14.4%)	0.98	(0.89- 1.08)	-0.26%	( 0.64%)
	Bacterial infectious disorders	15	( 0.2%)	19	( 0.3%)	0.79	(0.40- 1.55)	-0.07%	( 0.10%)
	Bacterial infections NEC	5	( 0.1%)	8	( 0.1%)	0.63	(0.21- 1.87)	-0.05%	( 0.06%)
	Clostridia infections	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.95)	0.00%	( 0.04%)
	Helicobacter infections	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.93)	-0.02%	( 0.03%)
	Legionella infections	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Listeria infections	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Staphylococcal infections	7	( 0.1%)	4	( 0.1%)	1.73	(0.53- 5.64)	0.05%	( 0.05%)
	Fungal infectious disorders	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.30)	-0.05%	( 0.03%)
	Fungal infections NEC	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.30)	-0.05%	( 0.03%)
	Infections - pathogen unspecified	777	(12.9%)	800	(13.3%)	0.97	(0.88- 1.07)	-0.38%	( 0.61%)
	Bone and joint infections	6	( 0.1%)	7	( 0.1%)	0.86	(0.29- 2.55)	-0.02%	( 0.06%)
	Cardiac infections	4	( 0.1%)	4	( 0.1%)	1.00	(0.25- 3.99)	0.00%	( 0.05%)
	Central nervous system and spinal infections	0	( 0.0%)	3	( 0.0%)	0.13	(0.01- 1.30)	-0.05%	( 0.03%)
	Dental and oral soft tissue infections	8	( 0.1%)	3	( 0.0%)	2.49	(0.76- 8.13)	0.08%	( 0.05%)
	Ear infections	19	( 0.3%)	28	( 0.5%)	0.68	(0.39- 1.21)	-0.15%	( 0.11%)
	Eye and eyelid infections	24	( 0.4%)	28	( 0.5%)	0.86	(0.50- 1.48)	-0.07%	( 0.12%)
	Abdominal and gastrointestinal infections	90	( 1.5%)	98	( 1.6%)	0.92	(0.69- 1.22)	-0.13%	( 0.23%)
	Infections NEC	18	( 0.3%)	14	( 0.2%)	1.29	(0.64- 2.57)	0.07%	( 0.09%)
	Lower respiratory tract and lung infections	434	( 7.2%)	456	( 7.6%)	0.95	(0.83- 1.08)	-0.36%	( 0.48%)
	Male reproductive tract infections M	11	( 0.2%)	9	( 0.2%)	1.22	(0.51- 2.94)	0.04%	( 0.09%)
	Sepsis, bacteraemia, viraemia and fungaemia NEC	29	( 0.5%)	26	( 0.4%)	1.12	(0.66- 1.89)	0.05%	( 0.12%)
	Skin structures and soft tissue infections	111	( 1.8%)	111	( 1.8%)	1.00	(0.77- 1.30)	0.00%	( 0.24%)
	Upper respiratory tract infections	4	( 0.1%)	4	( 0.1%)	1.00	(0.25- 4.00)	0.00%	( 0.05%)
	Urinary tract infections	105	( 1.7%)	103	( 1.7%)	1.02	(0.78- 1.34)	0.03%	( 0.24%)
	Hepatobiliary and spleen infections	3	( 0.0%)	0	( 0.0%)	7.36	(0.77- 70.80)	0.05%	( 0.03%)
	Mycobacterial infectious disorders	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Tuberculous infections	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Viral infectious disorders	77	( 1.3%)	62	( 1.0%)	1.24	(0.89- 1.73)	0.25%	( 0.19%)
	Herpes viral infections	34	( 0.6%)	34	( 0.6%)	1.00	(0.62- 1.61)	0.00%	( 0.14%)
	Influenza viral infections	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.87)	-0.02%	( 0.04%)
	Viral infections NEC	42	( 0.7%)	25	( 0.4%)	1.66	(1.03- 2.69)	0.28%	( 0.14%)
	Injury, poisoning and procedural complications	688	(11.4%)	705	(11.7%)	0.98	(0.88- 1.08)	-0.28%	( 0.58%)
	Bone and joint injuries	257	( 4.3%)	257	( 4.3%)	1.00	(0.84- 1.19)	0.00%	( 0.37%)
	Lower limb fractures and dislocations	90	( 1.5%)	76	( 1.3%)	1.19	(0.87- 1.61)	0.23%	( 0.21%)
	Fractures and dislocations NEC	72	( 1.2%)	89	( 1.5%)	0.81	(0.59- 1.10)	-0.28%	( 0.21%)
	Pelvic fractures and dislocations	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	0.00%	( 0.02%)
	Spinal fractures and dislocations	7	( 0.1%)	10	( 0.2%)	0.70	(0.27- 1.82)	-0.05%	( 0.07%)
	Thoracic cage fractures and dislocations	26	( 0.4%)	26	( 0.4%)	1.00	(0.58- 1.72)	0.00%	( 0.12%)
	Upper limb fractures and dislocations	76	( 1.3%)	68	( 1.1%)	1.12	(0.81- 1.55)	0.13%	( 0.20%)
	Injuries NEC	427	( 7.1%)	439	( 7.3%)	0.97	(0.85- 1.11)	-0.20%	( 0.47%)
	Chest and lung injuries NEC	13	( 0.2%)	12	( 0.2%)	1.08	(0.50- 2.38)	0.02%	( 0.08%)
	Eye injuries NEC	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.31)	-0.05%	( 0.03%)
	Muscle, tendon and ligament injuries	14	( 0.2%)	9	( 0.1%)	1.54	(0.68- 3.50)	0.08%	( 0.08%)
	Non-site specific injuries NEC	380	( 6.3%)	396	( 6.6%)	0.96	(0.83- 1.10)	-0.26%	( 0.45%)
	Site specific injuries NEC	21	( 0.3%)	15	( 0.2%)	1.40	(0.73- 2.69)	0.10%	( 0.10%)
	Cerebral injuries NEC	12	( 0.2%)	11	( 0.2%)	1.09	(0.48- 2.47)	0.02%	( 0.08%)
	Injuries by physical agents	7	( 0.1%)	3	( 0.0%)	2.24	(0.65- 7.73)	0.07%	( 0.05%)
	Thermal burns	7	( 0.1%)	3	( 0.0%)	2.24	(0.65- 7.73)	0.07%	( 0.05%)
	Medication errors	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.14)	-0.03%	( 0.02%)
	Overdoses	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.14)	-0.03%	( 0.02%)
	Chemical injury and poisoning	2	( 0.0%)	5	( 0.1%)	0.42	(0.10- 1.86)	-0.05%	( 0.04%)
	Chemical injuries	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.03%	( 0.02%)
	Poisoning and toxicity	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.86)	-0.02%	( 0.04%)
	Procedural related injuries and complications NEC	44	( 0.7%)	58	( 1.0%)	0.76	(0.52- 1.12)	-0.23%	( 0.17%)
	Cardiac and vascular procedural complications	1	( 0.0%)	0	( 0.0%)	7.37	(0.15-371.35)	0.02%	( 0.02%)
	Non-site specific procedural complications	42	( 0.7%)	58	( 1.0%)	0.73	(0.49- 1.07)	-0.26%	( 0.17%)
	Respiratory tract and thoracic cavity procedural complications	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.27)	0.02%	( 0.02%)
	Investigations	1753	(29.1%)	1782	(29.5%)	0.98	(0.92- 1.05)	-0.47%	( 0.83%)
	Cardiac and vascular investigations (excl enzyme tests)	792	(13.1%)	781	(12.9%)	1.01	(0.92- 1.12)	0.19%	( 0.61%)
	Cardiac function diagnostic procedures	219	( 3.6%)	186	( 3.1%)	1.18	(0.97- 1.43)	0.55%	( 0.33%)
	Cardiac imaging procedures	582	( 9.7%)	589	( 9.8%)	0.98	(0.88- 1.10)	-0.11%	( 0.54%)
	Vascular and lymphatic histopathology procedures	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Vascular imaging procedures NEC	63	( 1.0%)	65	( 1.1%)	0.97	(0.69- 1.37)	-0.03%	( 0.19%)
	Endocrine investigations (incl sex hormones)	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	0.00%	( 0.02%)
	Endocrine analyses and imaging NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	0.00%	( 0.02%)
	Enzyme investigations NEC	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.32)	0.03%	( 0.03%)
	Skeletal and cardiac muscle analyses	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.32)	0.03%	( 0.03%)
	Gastrointestinal investigations	509	( 8.4%)	519	( 8.6%)	0.98	(0.87- 1.11)	-0.16%	( 0.51%)
	Gastrointestinal and abdominal imaging procedures	509	( 8.4%)	519	( 8.6%)	0.98	(0.87- 1.11)	-0.16%	( 0.51%)
	Haematology investigations (incl blood groups)	12	( 0.2%)	11	( 0.2%)	1.09	(0.48- 2.47)	0.02%	( 0.08%)
	Haematological analyses NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.93)	-0.02%	( 0.03%)
	Bone marrow and immune tissue histopathology procedures	11	( 0.2%)	9	( 0.1%)	1.22	(0.51- 2.93)	0.03%	( 0.07%)
	Hepatobiliary investigations	17	( 0.3%)	17	( 0.3%)	1.00	(0.51- 1.96)	0.00%	( 0.10%)
	Hepatobiliary histopathology procedures	1	( 0.0%)	6	( 0.1%)	0.24	(0.05- 1.06)	-0.08%	( 0.04%)
	Hepatobiliary imaging procedures	10	( 0.2%)	5	( 0.1%)	1.95	(0.71- 5.37)	0.08%	( 0.06%)
	Liver function analyses	6	( 0.1%)	7	( 0.1%)	0.86	(0.29- 2.54)	-0.02%	( 0.06%)
	Immunology and allergy investigations	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.00)	0.00%	( 0.02%)
	Cell marker procedures	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.00)	0.00%	( 0.02%)
	Investigations, imaging and histopathology procedures NEC	519	( 8.6%)	548	( 9.1%)	0.95	(0.84- 1.07)	-0.48%	( 0.52%)
	Histopathology procedures NEC	33	( 0.5%)	42	( 0.7%)	0.79	(0.50- 1.24)	-0.15%	( 0.14%)
	Imaging procedures NEC	32	( 0.5%)	37	( 0.6%)	0.86	(0.54- 1.39)	-0.08%	( 0.14%)
	Investigations NEC	462	( 7.7%)	486	( 8.1%)	0.95	(0.84- 1.08)	-0.40%	( 0.49%)
	Metabolic, nutritional and blood gas investigations	3	( 0.0%)	0	( 0.0%)	7.36	(0.77- 70.80)	0.05%	( 0.03%)
	Carbohydrate tolerance analyses (incl diabetes)	3	( 0.0%)	0	( 0.0%)	7.36	(0.77- 70.80)	0.05%	( 0.03%)
	Musculoskeletal and soft tissue investigations (excl enzyme tests)	12	( 0.2%)	11	( 0.2%)	1.09	(0.48- 2.47)	0.02%	( 0.08%)
	Musculoskeletal and soft tissue histopathology procedures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Musculoskeletal and soft tissue imaging procedures	12	( 0.2%)	10	( 0.2%)	1.20	(0.52- 2.77)	0.03%	( 0.08%)
	Neurological, special senses and psychiatric investigations	12	( 0.2%)	3	( 0.0%)	3.32	(1.20- 9.12)	0.15%	( 0.06%)
	Central nervous system imaging procedures	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.33)	0.03%	( 0.03%)
	Neurologic diagnostic procedures	8	( 0.1%)	2	( 0.0%)	3.31	(0.96- 11.43)	0.10%	( 0.05%)
	Psychiatric investigations	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-373.20)	0.02%	( 0.02%)
	Renal and urinary tract investigations and urinalyses	168	( 2.8%)	168	( 2.8%)	1.00	(0.81- 1.24)	0.00%	( 0.30%)
	Urinary tract histopathology procedures	42	( 0.7%)	54	( 0.9%)	0.78	(0.52- 1.16)	-0.20%	( 0.16%)
	Urinary tract imaging procedures	138	( 2.3%)	130	( 2.2%)	1.06	(0.84- 1.35)	0.13%	( 0.27%)
	Reproductive organ and breast investigations (excl hormone analyses)	91	( 1.5%)	69	( 1.1%)	1.32	(0.97- 1.80)	0.37%	( 0.21%)
	Reproductive organ and breast histopathology procedures	85	( 1.4%)	68	( 1.1%)	1.25	(0.91- 1.71)	0.28%	( 0.20%)
	Reproductive organ and breast imaging procedures F	6	( 0.6%)	1	( 0.1%)	4.18	(0.95- 18.39)	0.49%	( 0.26%)
	Respiratory and pulmonary investigations (excl blood gases)	80	( 1.3%)	81	( 1.3%)	0.99	(0.73- 1.35)	-0.02%	( 0.21%)
	Respiratory tract and thoracic histopathology procedures	24	( 0.4%)	30	( 0.5%)	0.80	(0.47- 1.36)	-0.10%	( 0.12%)
	Respiratory tract and thoracic imaging procedures	53	( 0.9%)	59	( 1.0%)	0.90	(0.62- 1.30)	-0.10%	( 0.17%)
	Respiratory and pulmonary function diagnostic procedures	5	( 0.1%)	4	( 0.1%)	1.25	(0.34- 4.62)	0.02%	( 0.05%)
	Physical examination topics	9	( 0.1%)	11	( 0.2%)	0.82	(0.34- 1.97)	-0.03%	( 0.07%)
	Physical examination procedures	9	( 0.1%)	11	( 0.2%)	0.82	(0.34- 1.97)	-0.03%	( 0.07%)
	Metabolism and nutrition disorders	732	(12.1%)	674	(11.2%)	1.09	(0.98- 1.21)	0.97%	( 0.58%)
	Appetite and general nutritional disorders	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.66)	0.03%	( 0.04%)
	General nutritional disorders NEC	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.66)	0.03%	( 0.04%)
	Diabetic complications	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Diabetic complications NEC	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Electrolyte and fluid balance conditions	33	( 0.5%)	29	( 0.5%)	1.14	(0.69- 1.87)	0.07%	( 0.13%)
	Electrolyte imbalance NEC	8	( 0.1%)	8	( 0.1%)	1.00	(0.38- 2.66)	0.00%	( 0.07%)
	Total fluid volume decreased	25	( 0.4%)	22	( 0.4%)	1.14	(0.64- 2.01)	0.05%	( 0.11%)
	Glucose metabolism disorders (incl diabetes mellitus)	666	(11.0%)	616	(10.2%)	1.08	(0.97- 1.21)	0.83%	( 0.56%)
	Diabetes mellitus (incl subtypes)	651	(10.8%)	609	(10.1%)	1.07	(0.96- 1.20)	0.70%	( 0.56%)
	Hypoglycaemic conditions NEC	17	( 0.3%)	12	( 0.2%)	1.41	(0.68- 2.93)	0.08%	( 0.09%)
	Purine and pyrimidine metabolism disorders	40	( 0.7%)	31	( 0.5%)	1.29	(0.81- 2.06)	0.15%	( 0.14%)
	Disorders of purine metabolism	40	( 0.7%)	31	( 0.5%)	1.29	(0.81- 2.06)	0.15%	( 0.14%)
	Musculoskeletal and connective tissue disorders	427	( 7.1%)	379	( 6.3%)	1.13	(0.99- 1.30)	0.80%	( 0.45%)
	Bone disorders (excl congenital and fractures)	19	( 0.3%)	28	( 0.5%)	0.68	(0.39- 1.21)	-0.15%	( 0.11%)
	Metabolic bone disorders	15	( 0.2%)	26	( 0.4%)	0.59	(0.32- 1.08)	-0.18%	( 0.11%)
	Bone disorders NEC	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.66)	0.03%	( 0.04%)
	Connective tissue disorders (excl congenital)	18	( 0.3%)	29	( 0.5%)	0.63	(0.35- 1.11)	-0.18%	( 0.11%)
	Connective tissue disorders (excl LE)	18	( 0.3%)	26	( 0.4%)	0.69	(0.38- 1.25)	-0.13%	( 0.11%)
	Lupus erythematosus (incl subtypes)	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.30)	-0.05%	( 0.03%)
	Synovial and bursal disorders	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.54)	-0.03%	( 0.04%)
	Bursal disorders	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.09)	0.00%	( 0.03%)
	Synovial disorders	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.03%	( 0.02%)
	Fractures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.85)	-0.02%	( 0.02%)
	Pathological fractures and complications	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.85)	-0.02%	( 0.02%)
	Joint disorders	149	( 2.5%)	149	( 2.5%)	1.00	(0.80- 1.26)	0.00%	( 0.28%)
	Arthropathies NEC	68	( 1.1%)	65	( 1.1%)	1.05	(0.75- 1.47)	0.05%	( 0.19%)
	Joint related signs and symptoms	13	( 0.2%)	5	( 0.1%)	2.44	(0.97- 6.14)	0.13%	( 0.07%)
	Psoriatic arthropathies	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.97)	0.02%	( 0.02%)
	Rheumatoid arthropathies	31	( 0.5%)	37	( 0.6%)	0.84	(0.52- 1.35)	-0.10%	( 0.14%)
	Spondyloarthropathies	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.47)	0.02%	( 0.02%)
	Osteoarthropathies	44	( 0.7%)	48	( 0.8%)	0.92	(0.61- 1.38)	-0.07%	( 0.16%)
	Muscle disorders	128	( 2.1%)	76	( 1.3%)	1.67	(1.27- 2.20)	0.86%	( 0.23%)
	Muscle infections and inflammations	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.80)	-0.02%	( 0.02%)
	Muscle pains	73	( 1.2%)	67	( 1.1%)	1.09	(0.78- 1.52)	0.10%	( 0.20%)
	Muscle related signs and symptoms NEC	2	( 0.0%)	5	( 0.1%)	0.43	(0.10- 1.87)	-0.05%	( 0.04%)
	Myopathies	53	( 0.9%)	2	( 0.0%)	6.42	(3.78- 10.89)	0.85%	( 0.12%)
	Muscle weakness conditions	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.98)	0.00%	( 0.02%)
	Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)	3	( 0.0%)	6	( 0.1%)	0.51	(0.14- 1.90)	-0.05%	( 0.05%)
	Spine and neck deformities	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.73)	0.02%	( 0.03%)
	Intervertebral disc disorders NEC	1	( 0.0%)	5	( 0.1%)	0.26	(0.05- 1.31)	-0.07%	( 0.04%)
	Musculoskeletal and connective tissue disorders NEC	128	( 2.1%)	110	( 1.8%)	1.17	(0.90- 1.50)	0.30%	( 0.25%)
	Musculoskeletal and connective tissue signs and symptoms NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	0.00%	( 0.02%)
	Musculoskeletal and connective tissue infections and inflammations NEC	1	( 0.0%)	0	( 0.0%)	7.37	(0.15-371.66)	0.02%	( 0.02%)
	Musculoskeletal and connective tissue pain and discomfort	126	( 2.1%)	109	( 1.8%)	1.16	(0.90- 1.50)	0.28%	( 0.25%)
	Tendon, ligament and cartilage disorders	6	( 0.1%)	3	( 0.0%)	1.95	(0.53- 7.21)	0.05%	( 0.05%)
	Cartilage disorders	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.47)	0.02%	( 0.02%)
	Tendon disorders	5	( 0.1%)	3	( 0.0%)	1.65	(0.41- 6.60)	0.03%	( 0.05%)
	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	855	(14.2%)	924	(15.3%)	0.92	(0.84- 1.01)	-1.14%	( 0.65%)
	Breast neoplasms malignant and unspecified (incl nipple)	35	( 0.6%)	19	( 0.3%)	1.81	(1.06- 3.09)	0.27%	( 0.12%)
	Breast and nipple neoplasms malignant	35	( 0.6%)	19	( 0.3%)	1.81	(1.06- 3.09)	0.27%	( 0.12%)
	Endocrine neoplasms benign	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.30)	-0.02%	( 0.04%)
	Adrenal neoplasms benign	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.14)	-0.03%	( 0.02%)
	Endocrine neoplasms benign NEC	3	( 0.0%)	2	( 0.0%)	1.49	(0.26- 8.63)	0.02%	( 0.04%)
	Endocrine neoplasms malignant and unspecified	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.65)	0.03%	( 0.04%)
	Carcinoid tumours	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.80)	-0.02%	( 0.02%)
	Endocrine neoplasms malignant and unspecified NEC	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.74)	0.02%	( 0.03%)
	Thyroid neoplasms malignant	3	( 0.0%)	0	( 0.0%)	7.38	(0.77- 70.94)	0.05%	( 0.03%)
	Gastrointestinal neoplasms benign	5	( 0.1%)	8	( 0.1%)	0.63	(0.21- 1.87)	-0.05%	( 0.06%)
	Lip and oral cavity neoplasms benign	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Lower gastrointestinal neoplasms benign	5	( 0.1%)	6	( 0.1%)	0.83	(0.26- 2.72)	-0.02%	( 0.05%)
	Gastrointestinal neoplasms malignant and unspecified	142	( 2.4%)	160	( 2.7%)	0.89	(0.71- 1.11)	-0.30%	( 0.28%)
	Colonic neoplasms malignant	61	( 1.0%)	68	( 1.1%)	0.90	(0.64- 1.27)	-0.12%	( 0.19%)
	Colorectal and anal neoplasms malignancy unspecified	20	( 0.3%)	36	( 0.6%)	0.56	(0.33- 0.95)	-0.27%	( 0.12%)
	Gastric neoplasms malignant	25	( 0.4%)	20	( 0.3%)	1.25	(0.70- 2.24)	0.08%	( 0.11%)
	Gastrointestinal neoplasms malignant NEC	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Lip and oral cavity neoplasms malignant	8	( 0.1%)	7	( 0.1%)	1.15	(0.42- 3.15)	0.02%	( 0.06%)
	Oesophageal neoplasms malignant	17	( 0.3%)	20	( 0.3%)	0.85	(0.45- 1.62)	-0.05%	( 0.10%)
	Pancreatic neoplasms malignant (excl islet cell and carcinoid)	11	( 0.2%)	12	( 0.2%)	0.92	(0.41- 2.08)	-0.02%	( 0.08%)
	Rectal neoplasms malignant	7	( 0.1%)	9	( 0.1%)	0.78	(0.29- 2.07)	-0.03%	( 0.07%)
	Salivary gland neoplasms malignant	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.30)	-0.05%	( 0.03%)
	Small intestinal neoplasms malignant	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Haematopoietic neoplasms (excl leukaemias and lymphomas)	5	( 0.1%)	15	( 0.2%)	0.37	(0.15- 0.88)	-0.17%	( 0.07%)
	Haematologic neoplasms NEC	5	( 0.1%)	15	( 0.2%)	0.37	(0.15- 0.88)	-0.17%	( 0.07%)
	Hepatobiliary neoplasms malignant and unspecified	10	( 0.2%)	16	( 0.3%)	0.63	(0.29- 1.36)	-0.10%	( 0.08%)
	Bile duct neoplasms malignant	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	0.00%	( 0.02%)
	Gallbladder neoplasms malignant	6	( 0.1%)	7	( 0.1%)	0.85	(0.29- 2.54)	-0.02%	( 0.06%)
	Hepatic neoplasms malignant	4	( 0.1%)	8	( 0.1%)	0.51	(0.17- 1.59)	-0.07%	( 0.06%)
	Hepatobiliary neoplasms malignancy unspecified	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Hepatobiliary neoplasms malignant NEC	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.55)	-0.03%	( 0.04%)
	Leukaemias	33	( 0.5%)	35	( 0.6%)	0.94	(0.59- 1.52)	-0.03%	( 0.14%)
	Leukaemias acute lymphocytic	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.92)	-0.02%	( 0.03%)
	Leukaemias acute myeloid	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.64)	0.03%	( 0.04%)
	Leukaemias chronic lymphocytic	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Leukaemias myeloid NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Leukaemias NEC	18	( 0.3%)	27	( 0.4%)	0.67	(0.37- 1.20)	-0.15%	( 0.11%)
	Myelodysplastic syndromes	16	( 0.3%)	8	( 0.1%)	1.95	(0.87- 4.33)	0.13%	( 0.08%)
	Lymphomas Hodgkin's disease	5	( 0.1%)	2	( 0.0%)	2.37	(0.54- 10.41)	0.05%	( 0.04%)
	Hodgkin's disease NEC	5	( 0.1%)	2	( 0.0%)	2.37	(0.54- 10.41)	0.05%	( 0.04%)
	Lymphomas non-Hodgkin's B-cell	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.24)	0.05%	( 0.04%)
	B-cell lymphomas NEC	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.80)	0.02%	( 0.03%)
	B-cell small lymphocytic lymphomas	2	( 0.0%)	0	( 0.0%)	7.42	(0.46-118.66)	0.03%	( 0.02%)
	Lymphomas non-Hodgkin's unspecified histology	20	( 0.3%)	15	( 0.2%)	1.33	(0.69- 2.58)	0.08%	( 0.10%)
	Non-Hodgkin's lymphomas NEC	20	( 0.3%)	15	( 0.2%)	1.33	(0.69- 2.58)	0.08%	( 0.10%)
	Lymphomas NEC	13	( 0.2%)	1	( 0.0%)	5.55	(1.95- 15.83)	0.20%	( 0.06%)
	Lymphomas unspecified NEC	13	( 0.2%)	1	( 0.0%)	5.55	(1.95- 15.83)	0.20%	( 0.06%)
	Mesotheliomas	8	( 0.1%)	7	( 0.1%)	1.14	(0.42- 3.14)	0.02%	( 0.06%)
	Mesotheliomas malignant and unspecified	8	( 0.1%)	7	( 0.1%)	1.14	(0.42- 3.14)	0.02%	( 0.06%)
	Metastases	12	( 0.2%)	8	( 0.1%)	1.49	(0.62- 3.59)	0.07%	( 0.07%)
	Metastases to unknown and unspecified sites	12	( 0.2%)	8	( 0.1%)	1.49	(0.62- 3.59)	0.07%	( 0.07%)
	Miscellaneous and site unspecified neoplasms malignant and unspecified	11	( 0.2%)	15	( 0.2%)	0.74	(0.34- 1.59)	-0.07%	( 0.08%)
	Neoplasms malignant site unspecified NEC	10	( 0.2%)	14	( 0.2%)	0.72	(0.32- 1.60)	-0.07%	( 0.08%)
	Neoplasms unspecified malignancy and site unspecified NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.97)	0.00%	( 0.02%)
	Miscellaneous and site unspecified neoplasms benign	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	0.00%	( 0.02%)
	Aural neoplasms benign	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	0.00%	( 0.02%)
	Nervous system neoplasms benign	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.97)	0.00%	( 0.02%)
	Nervous system neoplasms benign NEC	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.28)	0.02%	( 0.02%)
	Neuromas	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Nervous system neoplasms malignant and unspecified NEC	7	( 0.1%)	11	( 0.2%)	0.64	(0.25- 1.62)	-0.07%	( 0.07%)
	Central nervous system neoplasms malignant NEC	7	( 0.1%)	10	( 0.2%)	0.70	(0.27- 1.82)	-0.05%	( 0.07%)
	Nervous system neoplasms unspecified malignancy NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.06)	0.00%	( 0.02%)
	Pineal neoplasms	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Plasma cell neoplasms	13	( 0.2%)	6	( 0.1%)	2.09	(0.85- 5.13)	0.12%	( 0.07%)
	Multiple myelomas	12	( 0.2%)	6	( 0.1%)	1.95	(0.77- 4.90)	0.10%	( 0.07%)
	Plasma cell neoplasms NEC	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-372.82)	0.02%	( 0.02%)
	Renal and urinary tract neoplasms malignant and unspecified	84	( 1.4%)	96	( 1.6%)	0.87	(0.65- 1.17)	-0.20%	( 0.22%)
	Bladder neoplasms malignant	60	( 1.0%)	71	( 1.2%)	0.85	(0.60- 1.19)	-0.18%	( 0.19%)
	Renal pelvis and ureter neoplasms malignant	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	0.00%	( 0.02%)
	Urinary tract neoplasms malignant NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.05)	0.00%	( 0.02%)
	Renal neoplasms malignant	25	( 0.4%)	25	( 0.4%)	1.00	(0.57- 1.74)	0.00%	( 0.12%)
	Reproductive neoplasms female malignant and unspecified F	8	( 0.8%)	11	( 1.1%)	0.73	(0.30- 1.79)	-0.29%	( 0.42%)
	Cervix neoplasms malignant F	1	( 0.1%)	2	( 0.2%)	0.51	(0.05- 4.94)	-0.10%	( 0.17%)
	Endometrial neoplasms malignant F	2	( 0.2%)	5	( 0.5%)	0.42	(0.10- 1.87)	-0.29%	( 0.26%)
	Female reproductive neoplasms unspecified malignancy F	4	( 0.4%)	0	( 0.0%)	7.38	(1.04- 52.39)	0.39%	( 0.19%)
	Ovarian neoplasms malignant (excl germ cell) F	5	( 0.5%)	4	( 0.4%)	1.25	(0.34- 4.63)	0.10%	( 0.29%)
	Uterine neoplasms malignant NEC F	1	( 0.1%)	1	( 0.1%)	1.00	(0.06- 16.04)	0.00%	( 0.14%)
	Reproductive neoplasms female benign F	2	( 0.2%)	0	( 0.0%)	7.39	(0.46-118.17)	0.19%	( 0.14%)
	Uterine neoplasms benign F	2	( 0.2%)	0	( 0.0%)	7.39	(0.46-118.17)	0.19%	( 0.14%)
	Reproductive neoplasms male malignant and unspecified M	149	( 3.0%)	161	( 3.2%)	0.92	(0.74- 1.15)	-0.24%	( 0.35%)
	Penile neoplasms malignant M	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.04%	( 0.03%)
	Prostatic neoplasms malignant M	147	( 2.9%)	159	( 3.2%)	0.92	(0.74- 1.15)	-0.24%	( 0.34%)
	Reproductive neoplasms male unspecified malignancy M	20	( 0.4%)	16	( 0.3%)	1.25	(0.65- 2.40)	0.08%	( 0.12%)
	Respiratory and mediastinal neoplasms malignant and unspecified	133	( 2.2%)	160	( 2.7%)	0.83	(0.66- 1.05)	-0.45%	( 0.28%)
	Laryngeal neoplasms malignant	7	( 0.1%)	6	( 0.1%)	1.17	(0.39- 3.46)	0.02%	( 0.06%)
	Mediastinal neoplasms malignancy unspecified NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	0.00%	( 0.02%)
	Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.88)	-0.02%	( 0.04%)
	Respiratory tract and pleural neoplasms malignant cell type unspecified NEC	124	( 2.1%)	150	( 2.5%)	0.83	(0.65- 1.05)	-0.43%	( 0.27%)
	Respiratory tract and pleural neoplasms malignancy unspecified NEC	2	( 0.0%)	2	( 0.0%)	1.01	(0.14- 7.18)	0.00%	( 0.03%)
	Cutaneous neoplasms benign	9	( 0.1%)	10	( 0.2%)	0.90	(0.37- 2.21)	-0.02%	( 0.07%)
	Skin neoplasms benign	9	( 0.1%)	10	( 0.2%)	0.90	(0.37- 2.21)	-0.02%	( 0.07%)
	Skin neoplasms malignant and unspecified	254	( 4.2%)	271	( 4.5%)	0.93	(0.79- 1.11)	-0.28%	( 0.37%)
	Skin melanomas (excl ocular)	31	( 0.5%)	28	( 0.5%)	1.11	(0.66- 1.84)	0.05%	( 0.13%)
	Skin neoplasms malignant and unspecified (excl melanoma)	235	( 3.9%)	253	( 4.2%)	0.93	(0.78- 1.11)	-0.30%	( 0.36%)
	Soft tissue neoplasms benign	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.75)	0.02%	( 0.03%)
	Soft tissue neoplasms benign NEC	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.75)	0.02%	( 0.03%)
	Soft tissue sarcomas	4	( 0.1%)	8	( 0.1%)	0.51	(0.17- 1.60)	-0.07%	( 0.06%)
	Fibrosarcomas malignant	4	( 0.1%)	8	( 0.1%)	0.51	(0.17- 1.60)	-0.07%	( 0.06%)
	Neoplasm related morbidities	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Oncologic complications and emergencies	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Nervous system disorders	669	(11.1%)	693	(11.5%)	0.96	(0.87- 1.07)	-0.39%	( 0.58%)
	Central nervous system infections and inflammations	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.00)	0.00%	( 0.02%)
	Encephalitis NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.00)	0.00%	( 0.02%)
	Central nervous system vascular disorders	366	( 6.1%)	385	( 6.4%)	0.95	(0.82- 1.10)	-0.31%	( 0.44%)
	Central nervous system haemorrhages and cerebrovascular accidents	252	( 4.2%)	267	( 4.4%)	0.94	(0.79- 1.12)	-0.25%	( 0.37%)
	Central nervous system vascular disorders NEC	3	( 0.0%)	6	( 0.1%)	0.52	(0.14- 1.91)	-0.05%	( 0.05%)
	Transient cerebrovascular events	146	( 2.4%)	145	( 2.4%)	1.01	(0.80- 1.27)	0.02%	( 0.28%)
	Cranial nerve disorders (excl neoplasms)	6	( 0.1%)	9	( 0.1%)	0.67	(0.24- 1.85)	-0.05%	( 0.06%)
	Cranial nerve disorders NEC	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.55)	-0.03%	( 0.04%)
	Facial cranial nerve disorders	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.96)	-0.02%	( 0.05%)
	Vagus nerve disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Demyelinating disorders	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.75)	0.02%	( 0.03%)
	Multiple sclerosis acute and progressive	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.75)	0.02%	( 0.03%)
	Encephalopathies	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Encephalopathies NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Headaches	24	( 0.4%)	31	( 0.5%)	0.78	(0.46- 1.32)	-0.12%	( 0.12%)
	Headaches NEC	22	( 0.4%)	25	( 0.4%)	0.88	(0.50- 1.56)	-0.05%	( 0.11%)
	Migraine headaches	2	( 0.0%)	7	( 0.1%)	0.33	(0.09- 1.21)	-0.08%	( 0.05%)
	Increased intracranial pressure and hydrocephalus	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	0.00%	( 0.02%)
	Hydrocephalic conditions	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	0.00%	( 0.02%)
	Movement disorders (incl parkinsonism)	29	( 0.5%)	29	( 0.5%)	1.00	(0.60- 1.67)	0.00%	( 0.13%)
	Paralysis and paresis (excl cranial nerve)	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-372.94)	0.02%	( 0.02%)
	Parkinson's disease and parkinsonism	26	( 0.4%)	27	( 0.4%)	0.96	(0.56- 1.65)	-0.02%	( 0.12%)
	Tremor (excl congenital)	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.95)	0.00%	( 0.04%)
	Neurological disorders NEC	180	( 3.0%)	185	( 3.1%)	0.97	(0.79- 1.19)	-0.08%	( 0.31%)
	Cerebellar coordination and balance disturbances	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-372.01)	0.02%	( 0.02%)
	Disturbances in consciousness NEC	107	( 1.8%)	107	( 1.8%)	1.00	(0.76- 1.31)	0.00%	( 0.24%)
	Neurological signs and symptoms NEC	68	( 1.1%)	71	( 1.2%)	0.96	(0.69- 1.34)	-0.05%	( 0.19%)
	Sensory abnormalities NEC	4	( 0.1%)	11	( 0.2%)	0.39	(0.14- 1.08)	-0.12%	( 0.06%)
	Coma states	3	( 0.0%)	0	( 0.0%)	7.39	(0.77- 71.06)	0.05%	( 0.03%)
	Nervous system disorders NEC	0	( 0.0%)	2	( 0.0%)	0.13	(0.01- 2.16)	-0.03%	( 0.02%)
	Neuromuscular disorders	11	( 0.2%)	4	( 0.1%)	2.54	(0.92- 6.99)	0.12%	( 0.06%)
	Motor neurone diseases	9	( 0.1%)	2	( 0.0%)	3.56	(1.09- 11.62)	0.12%	( 0.05%)
	Neuromuscular junction dysfunction	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Peripheral neuropathies	30	( 0.5%)	17	( 0.3%)	1.74	(0.98- 3.08)	0.22%	( 0.11%)
	Acute polyneuropathies	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.76)	0.02%	( 0.03%)
	Mononeuropathies	21	( 0.3%)	9	( 0.1%)	2.23	(1.09- 4.56)	0.20%	( 0.09%)
	Peripheral neuropathies NEC	8	( 0.1%)	8	( 0.1%)	1.00	(0.38- 2.66)	0.00%	( 0.07%)
	Seizures (incl subtypes)	23	( 0.4%)	24	( 0.4%)	0.96	(0.54- 1.70)	-0.02%	( 0.11%)
	Seizures and seizure disorders NEC	23	( 0.4%)	24	( 0.4%)	0.96	(0.54- 1.70)	-0.02%	( 0.11%)
	Sleep disturbances (incl subtypes)	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.30)	0.02%	( 0.02%)
	Narcolepsy and hypersomnia	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.30)	0.02%	( 0.02%)
	Spinal cord and nerve root disorders	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.87)	-0.02%	( 0.04%)
	Spinal cord and nerve root disorders NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.87)	-0.02%	( 0.04%)
	Mental impairment disorders	53	( 0.9%)	52	( 0.9%)	1.02	(0.70- 1.50)	0.02%	( 0.17%)
	Alzheimer's disease (incl subtypes)	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.03%	( 0.02%)
	Dementia (excl Alzheimer's type)	46	( 0.8%)	46	( 0.8%)	1.00	(0.66- 1.51)	0.00%	( 0.16%)
	Memory loss (excl dementia)	7	( 0.1%)	5	( 0.1%)	1.40	(0.45- 4.34)	0.03%	( 0.06%)
	Psychiatric disorders	76	( 1.3%)	80	( 1.3%)	0.95	(0.69- 1.30)	-0.07%	( 0.21%)
	Anxiety disorders and symptoms	18	( 0.3%)	17	( 0.3%)	1.06	(0.55- 2.06)	0.02%	( 0.10%)
	Anxiety symptoms	6	( 0.1%)	3	( 0.0%)	1.95	(0.53- 7.19)	0.05%	( 0.05%)
	Anxiety disorders NEC	12	( 0.2%)	14	( 0.2%)	0.86	(0.40- 1.85)	-0.03%	( 0.08%)
	Deliria (incl confusion)	5	( 0.1%)	5	( 0.1%)	1.00	(0.29- 3.46)	0.00%	( 0.05%)
	Confusion and disorientation	5	( 0.1%)	5	( 0.1%)	1.00	(0.29- 3.46)	0.00%	( 0.05%)
	Depressed mood disorders and disturbances	47	( 0.8%)	54	( 0.9%)	0.87	(0.59- 1.28)	-0.12%	( 0.17%)
	Depressive disorders	47	( 0.8%)	54	( 0.9%)	0.87	(0.59- 1.28)	-0.12%	( 0.17%)
	Psychiatric disorders NEC	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.39)	0.02%	( 0.02%)
	Substance-related disorders	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.39)	0.02%	( 0.02%)
	Schizophrenia and other psychotic disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Psychotic disorder NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Sexual dysfunctions, disturbances and gender identity disorders	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.86)	-0.02%	( 0.04%)
	Sexual desire disorders	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.86)	-0.02%	( 0.04%)
	Sleep disorders and disturbances	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.72)	0.02%	( 0.03%)
	Disturbances in initiating and maintaining sleep	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.72)	0.02%	( 0.03%)
	Suicidal and self-injurious behaviours NEC	5	( 0.1%)	7	( 0.1%)	0.72	(0.23- 2.22)	-0.03%	( 0.06%)
	Suicidal and self-injurious behaviour	5	( 0.1%)	7	( 0.1%)	0.72	(0.23- 2.22)	-0.03%	( 0.06%)
	Renal and urinary disorders	156	( 2.6%)	184	( 3.0%)	0.85	(0.68- 1.05)	-0.46%	( 0.30%)
	Bladder and bladder neck disorders (excl calculi)	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Bladder disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Genitourinary tract disorders NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.92)	-0.02%	( 0.03%)
	Genital and urinary tract disorders NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.92)	-0.02%	( 0.03%)
	Nephropathies	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Glomerulonephritis and nephrotic syndrome	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-372.83)	0.02%	( 0.02%)
	Nephritis NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Nephropathies and tubular disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Renal disorders (excl nephropathies)	55	( 0.9%)	73	( 1.2%)	0.75	(0.53- 1.07)	-0.30%	( 0.19%)
	Renal disorders NEC	2	( 0.0%)	5	( 0.1%)	0.42	(0.10- 1.87)	-0.05%	( 0.04%)
	Renal failure and impairment	49	( 0.8%)	67	( 1.1%)	0.73	(0.51- 1.05)	-0.30%	( 0.18%)
	Renal neoplasms	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.30)	0.03%	( 0.03%)
	Renal obstructive disorders	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.01)	0.00%	( 0.02%)
	Renal vascular and ischaemic conditions	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	0.00%	( 0.02%)
	Urethral disorders (excl calculi)	17	( 0.3%)	19	( 0.3%)	0.90	(0.47- 1.72)	-0.03%	( 0.10%)
	Structural and obstructive urethral disorders (excl congenital)	17	( 0.3%)	19	( 0.3%)	0.90	(0.47- 1.72)	-0.03%	( 0.10%)
	Urinary tract signs and symptoms	56	( 0.9%)	47	( 0.8%)	1.19	(0.81- 1.75)	0.15%	( 0.17%)
	Urinary abnormalities	12	( 0.2%)	18	( 0.3%)	0.67	(0.33- 1.37)	-0.10%	( 0.09%)
	Bladder and urethral symptoms	27	( 0.4%)	15	( 0.2%)	1.77	(0.97- 3.24)	0.20%	( 0.11%)
	Urinary tract signs and symptoms NEC	18	( 0.3%)	15	( 0.2%)	1.20	(0.61- 2.37)	0.05%	( 0.10%)
	Urolithiases	31	( 0.5%)	47	( 0.8%)	0.66	(0.42- 1.03)	-0.27%	( 0.15%)
	Urinary tract lithiasis (excl renal)	31	( 0.5%)	47	( 0.8%)	0.66	(0.42- 1.03)	-0.27%	( 0.15%)
	Reproductive system and breast disorders	61	( 1.0%)	60	( 1.0%)	1.02	(0.71- 1.45)	0.02%	( 0.18%)
	Breast disorders	8	( 0.1%)	3	( 0.0%)	2.48	(0.76- 8.10)	0.08%	( 0.05%)
	Breast disorders NEC	8	( 0.1%)	3	( 0.0%)	2.48	(0.76- 8.10)	0.08%	( 0.05%)
	Penile and scrotal disorders (excl infections and inflammations) M	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.20)	0.06%	( 0.04%)
	Penile disorders NEC (excl erection and ejaculation) M	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.20)	0.06%	( 0.04%)
	Testicular and epididymal disorders M	0	( 0.0%)	3	( 0.1%)	0.14	(0.01- 1.30)	-0.06%	( 0.03%)
	Testicular and epididymal disorders NEC M	0	( 0.0%)	3	( 0.1%)	0.14	(0.01- 1.30)	-0.06%	( 0.03%)
	Ovarian and fallopian tube disorders F	0	( 0.0%)	2	( 0.2%)	0.14	(0.01- 2.16)	-0.19%	( 0.14%)
	Ovarian and fallopian tube cysts and neoplasms F	0	( 0.0%)	2	( 0.2%)	0.14	(0.01- 2.16)	-0.19%	( 0.14%)
	Prostatic disorders (excl infections and inflammations) M	40	( 0.8%)	49	( 1.0%)	0.82	(0.54- 1.24)	-0.18%	( 0.19%)
	Prostatic signs, symptoms and disorders NEC M	40	( 0.8%)	49	( 1.0%)	0.82	(0.54- 1.24)	-0.18%	( 0.19%)
	Reproductive tract disorders NEC	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.44)	0.02%	( 0.02%)
	Reproductive tract disorders NEC (excl neoplasms)	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.44)	0.02%	( 0.02%)
	Uterine, pelvic and broad ligament disorders F	1	( 0.1%)	2	( 0.2%)	0.51	(0.05- 4.92)	-0.10%	( 0.17%)
	Pelvic prolapse conditions	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Vulvovaginal disorders (excl infections and inflammations) F	7	( 0.7%)	0	( 0.0%)	7.42	(1.69- 32.63)	0.68%	( 0.26%)
	Vulvovaginal disorders NEC F	7	( 0.7%)	0	( 0.0%)	7.42	(1.69- 32.63)	0.68%	( 0.26%)
	Respiratory, thoracic and mediastinal disorders	496	( 8.2%)	412	( 6.8%)	1.21	(1.06- 1.38)	1.40%	( 0.48%)
	Bronchial disorders (excl neoplasms)	93	( 1.5%)	70	( 1.2%)	1.33	(0.98- 1.80)	0.38%	( 0.21%)
	Bronchial conditions NEC	7	( 0.1%)	4	( 0.1%)	1.73	(0.53- 5.63)	0.05%	( 0.05%)
	Bronchospasm and obstruction	86	( 1.4%)	66	( 1.1%)	1.30	(0.95- 1.79)	0.33%	( 0.20%)
	Thoracic disorders (excl lung and pleura)	3	( 0.0%)	2	( 0.0%)	1.49	(0.26- 8.61)	0.02%	( 0.04%)
	Mediastinal disorders	3	( 0.0%)	2	( 0.0%)	1.49	(0.26- 8.61)	0.02%	( 0.04%)
	Lower respiratory tract disorders (excl obstruction and infection)	50	( 0.8%)	50	( 0.8%)	1.00	(0.68- 1.48)	0.00%	( 0.17%)
	Lower respiratory tract inflammatory and immunologic conditions	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.86)	-0.02%	( 0.04%)
	Parenchymal lung disorders NEC	48	( 0.8%)	48	( 0.8%)	1.00	(0.67- 1.49)	0.00%	( 0.16%)
	Pleural disorders	59	( 1.0%)	51	( 0.8%)	1.16	(0.80- 1.68)	0.13%	( 0.17%)
	Pleural infections and inflammations	28	( 0.5%)	24	( 0.4%)	1.17	(0.68- 2.01)	0.07%	( 0.12%)
	Pneumothorax and pleural effusions NEC	33	( 0.5%)	27	( 0.4%)	1.22	(0.74- 2.03)	0.10%	( 0.13%)
	Pulmonary vascular disorders	59	( 1.0%)	51	( 0.8%)	1.16	(0.80- 1.68)	0.13%	( 0.17%)
	Pulmonary thrombotic and embolic conditions	59	( 1.0%)	51	( 0.8%)	1.16	(0.80- 1.68)	0.13%	( 0.17%)
	Respiratory disorders NEC	213	( 3.5%)	171	( 2.8%)	1.25	(1.02- 1.52)	0.70%	( 0.32%)
	Breathing abnormalities	183	( 3.0%)	155	( 2.6%)	1.18	(0.96- 1.46)	0.47%	( 0.30%)
	Coughing and associated symptoms	20	( 0.3%)	12	( 0.2%)	1.65	(0.83- 3.30)	0.13%	( 0.09%)
	Lower respiratory tract signs and symptoms	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Respiratory signs and symptoms NEC	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.10)	0.00%	( 0.03%)
	Upper respiratory tract signs and symptoms	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.84)	0.02%	( 0.04%)
	Respiratory failures (excl neonatal)	1	( 0.0%)	0	( 0.0%)	7.42	(0.15-374.06)	0.02%	( 0.02%)
	Respiratory tract disorders NEC	5	( 0.1%)	1	( 0.0%)	3.79	(0.76- 18.76)	0.07%	( 0.04%)
	Upper respiratory tract disorders (excl infections)	60	( 1.0%)	48	( 0.8%)	1.25	(0.86- 1.82)	0.20%	( 0.17%)
	Nasal disorders NEC	57	( 0.9%)	46	( 0.8%)	1.24	(0.84- 1.83)	0.18%	( 0.17%)
	Nasal congestion and inflammations	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.99)	0.00%	( 0.02%)
	Pharyngeal disorders (excl infections and neoplasms)	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.75)	0.02%	( 0.03%)
	Skin and subcutaneous tissue disorders	201	( 3.3%)	199	( 3.3%)	1.01	(0.83- 1.23)	0.03%	( 0.33%)
	Angioedema and urticaria	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.03%	( 0.02%)
	Urticarias	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.03%	( 0.02%)
	Cornification and dystrophic skin disorders	7	( 0.1%)	11	( 0.2%)	0.64	(0.25- 1.62)	-0.07%	( 0.07%)
	Skin preneoplastic conditions NEC	7	( 0.1%)	11	( 0.2%)	0.64	(0.25- 1.62)	-0.07%	( 0.07%)
	Epidermal and dermal conditions	161	( 2.7%)	157	( 2.6%)	1.03	(0.82- 1.28)	0.07%	( 0.29%)
	Bullous conditions	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.41)	0.03%	( 0.02%)
	Connective tissue disorders	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.16)	0.03%	( 0.02%)
	Dermal and epidermal conditions NEC	92	( 1.5%)	104	( 1.7%)	0.88	(0.67- 1.17)	-0.20%	( 0.23%)
	Dermatitis and eczema	28	( 0.5%)	15	( 0.2%)	1.83	(1.01- 3.33)	0.22%	( 0.11%)
	Skin injuries and mechanical dermatoses	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.96)	0.00%	( 0.02%)
	Pruritus NEC	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.23)	0.02%	( 0.02%)
	Rashes, eruptions and exanthems NEC	33	( 0.5%)	34	( 0.6%)	0.97	(0.60- 1.57)	-0.02%	( 0.14%)
	Psoriatic conditions	5	( 0.1%)	5	( 0.1%)	1.00	(0.29- 3.46)	0.00%	( 0.05%)
	Pigmentation disorders	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	0.00%	( 0.02%)
	Pigmentation changes NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	0.00%	( 0.02%)
	Skin and subcutaneous tissue disorders NEC	19	( 0.3%)	27	( 0.4%)	0.71	(0.40- 1.26)	-0.13%	( 0.11%)
	Skin and subcutaneous tissue ulcerations	18	( 0.3%)	27	( 0.4%)	0.67	(0.37- 1.20)	-0.15%	( 0.11%)
	Skin and subcutaneous malformations and anomalies NEC	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.58)	0.02%	( 0.02%)
	Skin appendage conditions	16	( 0.3%)	6	( 0.1%)	2.48	(1.08- 5.72)	0.17%	( 0.08%)
	Apocrine and eccrine gland disorders	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.30)	0.03%	( 0.03%)
	Nail and nail bed conditions (excl infections and infestations)	12	( 0.2%)	4	( 0.1%)	2.72	(1.02- 7.23)	0.13%	( 0.07%)
	Pilar disorders NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.95)	0.00%	( 0.02%)
	Social circumstances	3	( 0.0%)	6	( 0.1%)	0.51	(0.14- 1.90)	-0.05%	( 0.05%)
	Legal issues	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Criminal activity	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	0.00%	( 0.03%)
	Lifestyle issues	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Alcohol product use	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.00)	0.00%	( 0.02%)
	Disability issues	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Social issues NEC	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Surgical and medical procedures	2558	(42.4%)	2557	(42.4%)	0.99	(0.94- 1.05)	0.03%	( 0.90%)
	Vascular therapeutic procedures	727	(12.1%)	798	(13.2%)	0.90	(0.82- 1.00)	-1.17%	( 0.61%)
	Aortic therapeutic procedures	41	( 0.7%)	68	( 1.1%)	0.61	(0.42- 0.88)	-0.45%	( 0.17%)
	Arterial therapeutic procedures (excl aortic)	625	(10.4%)	665	(11.0%)	0.93	(0.84- 1.04)	-0.66%	( 0.56%)
	Vascular therapeutic procedures NEC	58	( 1.0%)	61	( 1.0%)	0.95	(0.66- 1.36)	-0.05%	( 0.18%)
	Venous therapeutic procedures	23	( 0.4%)	34	( 0.6%)	0.68	(0.40- 1.14)	-0.18%	( 0.12%)
	Bone and joint therapeutic procedures	577	( 9.6%)	542	( 9.0%)	1.07	(0.95- 1.20)	0.58%	( 0.53%)
	Bone therapeutic procedures NEC	9	( 0.1%)	7	( 0.1%)	1.29	(0.48- 3.42)	0.03%	( 0.07%)
	Joint therapeutic procedures	468	( 7.8%)	413	( 6.8%)	1.14	(1.00- 1.30)	0.91%	( 0.47%)
	Limb therapeutic procedures	120	( 2.0%)	140	( 2.3%)	0.86	(0.67- 1.09)	-0.33%	( 0.26%)
	Fracture treatments (excl skull and spine)	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Breast therapeutic procedures	13	( 0.2%)	10	( 0.2%)	1.30	(0.57- 2.94)	0.05%	( 0.08%)
	Mastectomies	8	( 0.1%)	7	( 0.1%)	1.14	(0.42- 3.15)	0.02%	( 0.06%)
	Breast therapeutic procedures NEC	5	( 0.1%)	4	( 0.1%)	1.25	(0.34- 4.61)	0.02%	( 0.05%)
	Cardiac therapeutic procedures	223	( 3.7%)	259	( 4.3%)	0.86	(0.72- 1.03)	-0.60%	( 0.36%)
	Cardiac device therapeutic procedures	158	( 2.6%)	188	( 3.1%)	0.84	(0.68- 1.03)	-0.50%	( 0.30%)
	Cardiac valve therapeutic procedures	19	( 0.3%)	22	( 0.4%)	0.86	(0.47- 1.59)	-0.05%	( 0.11%)
	Cardiac therapeutic procedures NEC	63	( 1.0%)	67	( 1.1%)	0.94	(0.67- 1.33)	-0.07%	( 0.19%)
	Nervous system, skull and spine therapeutic procedures	62	( 1.0%)	84	( 1.4%)	0.74	(0.53- 1.02)	-0.36%	( 0.20%)
	Autonomic nerve therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.28)	0.02%	( 0.02%)
	Peripheral nerve therapeutic procedures	21	( 0.3%)	28	( 0.5%)	0.75	(0.43- 1.32)	-0.12%	( 0.12%)
	Skull and brain therapeutic procedures	6	( 0.1%)	3	( 0.0%)	1.95	(0.53- 7.20)	0.05%	( 0.05%)
	Spine and spinal cord therapeutic procedures	37	( 0.6%)	53	( 0.9%)	0.70	(0.46- 1.06)	-0.27%	( 0.16%)
	Endocrine gland therapeutic procedures	11	( 0.2%)	2	( 0.0%)	4.00	(1.35- 11.86)	0.15%	( 0.06%)
	Hormonal therapeutic procedures NEC	4	( 0.1%)	0	( 0.0%)	7.40	(1.04- 52.52)	0.07%	( 0.03%)
	Parathyroid gland therapeutic procedures	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.79)	0.02%	( 0.03%)
	Pituitary and hypothalamic therapeutic procedures	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.26)	0.03%	( 0.02%)
	Thyroid therapeutic procedures	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.29)	0.03%	( 0.03%)
	Eye therapeutic procedures	462	( 7.7%)	444	( 7.4%)	1.04	(0.92- 1.19)	0.30%	( 0.48%)
	Eyelid therapeutic procedures	28	( 0.5%)	19	( 0.3%)	1.47	(0.83- 2.60)	0.15%	( 0.11%)
	Lacrimal apparatus therapeutic procedures	12	( 0.2%)	13	( 0.2%)	0.92	(0.42- 2.02)	-0.02%	( 0.08%)
	Lens therapeutic procedures	393	( 6.5%)	382	( 6.3%)	1.03	(0.90- 1.19)	0.18%	( 0.45%)
	Eye therapeutic procedures NEC	39	( 0.6%)	48	( 0.8%)	0.81	(0.53- 1.24)	-0.15%	( 0.15%)
	Orbit and globe therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.35)	0.02%	( 0.02%)
	Retinal therapeutic procedures	12	( 0.2%)	3	( 0.0%)	3.33	(1.21- 9.15)	0.15%	( 0.06%)
	Gastrointestinal therapeutic procedures	430	( 7.1%)	429	( 7.1%)	1.00	(0.88- 1.15)	0.02%	( 0.47%)
	Anorectal therapeutic procedures	59	( 1.0%)	51	( 0.8%)	1.16	(0.80- 1.68)	0.13%	( 0.17%)
	Gastric therapeutic procedures	6	( 0.1%)	6	( 0.1%)	1.00	(0.32- 3.10)	0.00%	( 0.06%)
	Gastrointestinal therapeutic procedures NEC	39	( 0.6%)	46	( 0.8%)	0.85	(0.55- 1.30)	-0.12%	( 0.15%)
	Hernia repairs	272	( 4.5%)	257	( 4.3%)	1.06	(0.89- 1.26)	0.25%	( 0.37%)
	Large intestine therapeutic procedures	59	( 1.0%)	67	( 1.1%)	0.88	(0.62- 1.25)	-0.13%	( 0.19%)
	Abdominal therapeutic procedures NEC	7	( 0.1%)	9	( 0.1%)	0.78	(0.29- 2.07)	-0.03%	( 0.07%)
	Oesophageal therapeutic procedures	7	( 0.1%)	14	( 0.2%)	0.51	(0.22- 1.21)	-0.12%	( 0.08%)
	Pancreatic therapeutic procedures	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.01)	0.00%	( 0.02%)
	Small intestine therapeutic procedures	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.55)	-0.03%	( 0.04%)
	Head and neck therapeutic procedures	134	( 2.2%)	113	( 1.9%)	1.19	(0.93- 1.53)	0.35%	( 0.26%)
	Dental and gingival therapeutic procedures	34	( 0.6%)	21	( 0.3%)	1.61	(0.95- 2.72)	0.22%	( 0.12%)
	Facial therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.54)	0.02%	( 0.02%)
	Laryngeal therapeutic procedures	9	( 0.1%)	10	( 0.2%)	0.90	(0.37- 2.21)	-0.02%	( 0.07%)
	Nasal therapeutic procedures	46	( 0.8%)	39	( 0.6%)	1.18	(0.77- 1.81)	0.12%	( 0.15%)
	Paranasal therapeutic procedures	14	( 0.2%)	17	( 0.3%)	0.82	(0.41- 1.67)	-0.05%	( 0.09%)
	Pharyngeal therapeutic procedures	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.97)	0.00%	( 0.02%)
	Salivary gland therapeutic procedures	7	( 0.1%)	9	( 0.1%)	0.78	(0.29- 2.07)	-0.03%	( 0.07%)
	Tongue therapeutic procedures	6	( 0.1%)	8	( 0.1%)	0.75	(0.26- 2.14)	-0.03%	( 0.06%)
	Head, neck and oral cavity therapeutic procedures NEC	23	( 0.4%)	16	( 0.3%)	1.44	(0.77- 2.69)	0.12%	( 0.10%)
	Hepatobiliary therapeutic procedures	70	( 1.2%)	73	( 1.2%)	0.96	(0.69- 1.33)	-0.05%	( 0.20%)
	Biliary tract and gallbladder therapeutic procedures	70	( 1.2%)	72	( 1.2%)	0.97	(0.70- 1.35)	-0.03%	( 0.20%)
	Hepatic therapeutic procedures	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.74)	-0.02%	( 0.02%)
	Haematological and lymphoid tissue therapeutic procedures	47	( 0.8%)	44	( 0.7%)	1.07	(0.71- 1.61)	0.05%	( 0.16%)
	Blood and blood product treatment	37	( 0.6%)	33	( 0.5%)	1.12	(0.70- 1.79)	0.07%	( 0.14%)
	Lymphoid tissue therapeutic procedures	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.25)	0.03%	( 0.02%)
	Haematological therapeutic procedures NEC	8	( 0.1%)	14	( 0.2%)	0.58	(0.25- 1.34)	-0.10%	( 0.08%)
	Male genital tract therapeutic procedures M	182	( 3.6%)	178	( 3.6%)	1.02	(0.83- 1.26)	0.08%	( 0.37%)
	Epididymal therapeutic procedures M	3	( 0.1%)	7	( 0.1%)	0.45	(0.13- 1.55)	-0.08%	( 0.06%)
	Penile therapeutic procedures M	21	( 0.4%)	28	( 0.6%)	0.75	(0.43- 1.32)	-0.14%	( 0.14%)
	Prostatic therapeutic procedures M	142	( 2.8%)	119	( 2.4%)	1.20	(0.94- 1.52)	0.46%	( 0.32%)
	Male genital tract therapeutic procedures NEC M	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.06%	( 0.04%)
	Testicular and scrotal therapeutic procedures M	19	( 0.4%)	24	( 0.5%)	0.79	(0.43- 1.44)	-0.10%	( 0.13%)
	Obstetric and gynaecological therapeutic procedures F	52	( 5.1%)	45	( 4.4%)	1.16	(0.78- 1.72)	0.68%	( 0.94%)
	Cervix therapeutic procedures F	17	( 1.7%)	5	( 0.5%)	2.99	(1.30- 6.90)	1.17%	( 0.45%)
	Ovarian therapeutic procedures F	0	( 0.0%)	1	( 0.1%)	0.14	(0.00- 6.86)	-0.10%	( 0.10%)
	Uterine therapeutic procedures F	17	( 1.7%)	27	( 2.6%)	0.63	(0.35- 1.14)	-0.97%	( 0.64%)
	Vaginal therapeutic procedures F	19	( 1.9%)	15	( 1.5%)	1.27	(0.65- 2.49)	0.39%	( 0.56%)
	Renal and urinary tract therapeutic procedures	94	( 1.6%)	123	( 2.0%)	0.76	(0.59- 1.00)	-0.48%	( 0.24%)
	Bladder therapeutic procedures	18	( 0.3%)	31	( 0.5%)	0.59	(0.34- 1.03)	-0.22%	( 0.12%)
	Renal therapeutic procedures	29	( 0.5%)	51	( 0.8%)	0.58	(0.37- 0.89)	-0.36%	( 0.15%)
	Therapeutic bladder catheterisation	49	( 0.8%)	46	( 0.8%)	1.07	(0.71- 1.59)	0.05%	( 0.16%)
	Urethral therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.40)	0.02%	( 0.02%)
	Respiratory tract therapeutic procedures	11	( 0.2%)	8	( 0.1%)	1.37	(0.56- 3.37)	0.05%	( 0.07%)
	Bronchial and pulmonary therapeutic procedures	9	( 0.1%)	4	( 0.1%)	2.16	(0.73- 6.41)	0.08%	( 0.06%)
	Chest wall and mediastinal therapeutic procedures	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.33)	0.03%	( 0.03%)
	Pleural therapeutic procedures	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Tracheal therapeutic procedures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Skin and subcutaneous tissue therapeutic procedures	100	( 1.7%)	102	( 1.7%)	0.98	(0.74- 1.29)	-0.03%	( 0.23%)
	Nail therapeutic procedures	10	( 0.2%)	13	( 0.2%)	0.77	(0.34- 1.75)	-0.05%	( 0.08%)
	Skin and subcutaneous tissue therapeutic procedures NEC	8	( 0.1%)	5	( 0.1%)	1.58	(0.53- 4.69)	0.05%	( 0.06%)
	Skin grafts	8	( 0.1%)	6	( 0.1%)	1.33	(0.47- 3.80)	0.03%	( 0.06%)
	Skin lesion excisions	76	( 1.3%)	79	( 1.3%)	0.96	(0.70- 1.32)	-0.05%	( 0.21%)
	Soft tissue therapeutic procedures	54	( 0.9%)	45	( 0.7%)	1.20	(0.81- 1.78)	0.15%	( 0.16%)
	Fascial and bursal therapeutic procedures	31	( 0.5%)	30	( 0.5%)	1.03	(0.63- 1.71)	0.02%	( 0.13%)
	Tendon therapeutic procedures	20	( 0.3%)	14	( 0.2%)	1.42	(0.73- 2.79)	0.10%	( 0.10%)
	Soft tissue therapeutic procedures NEC	3	( 0.0%)	2	( 0.0%)	1.49	(0.26- 8.62)	0.02%	( 0.04%)
	Therapeutic procedures and supportive care NEC	275	( 4.6%)	304	( 5.0%)	0.90	(0.77- 1.06)	-0.48%	( 0.39%)
	Anaesthesia and allied procedures	92	( 1.5%)	82	( 1.4%)	1.12	(0.83- 1.51)	0.17%	( 0.22%)
	Analgesia supportive care	0	( 0.0%)	4	( 0.1%)	0.14	(0.02- 0.96)	-0.07%	( 0.03%)
	Chemotherapies	46	( 0.8%)	56	( 0.9%)	0.82	(0.56- 1.21)	-0.17%	( 0.17%)
	Therapeutic procedures NEC	106	( 1.8%)	121	( 2.0%)	0.88	(0.67- 1.14)	-0.25%	( 0.25%)
	Phototherapies	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.97)	0.00%	( 0.02%)
	Radiotherapies site unspecified	46	( 0.8%)	57	( 0.9%)	0.81	(0.55- 1.19)	-0.18%	( 0.17%)
	Drug withdrawal therapies	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Dietary and nutritional therapies	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.05)	0.00%	( 0.02%)
	Vascular disorders	261	( 4.3%)	314	( 5.2%)	0.83	(0.70- 0.98)	-0.88%	( 0.39%)
	Aneurysms and artery dissections	64	( 1.1%)	69	( 1.1%)	0.93	(0.66- 1.30)	-0.08%	( 0.19%)
	Aneurysms and dissections non-site specific	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.35)	0.03%	( 0.03%)
	Aortic aneurysms and dissections	60	( 1.0%)	65	( 1.1%)	0.92	(0.65- 1.31)	-0.08%	( 0.18%)
	Peripheral aneurysms and dissections	5	( 0.1%)	4	( 0.1%)	1.25	(0.34- 4.62)	0.02%	( 0.05%)
	Arteriosclerosis, stenosis, vascular insufficiency and necrosis	30	( 0.5%)	22	( 0.4%)	1.36	(0.79- 2.35)	0.13%	( 0.12%)
	Aortic necrosis and vascular insufficiency	5	( 0.1%)	2	( 0.0%)	2.35	(0.53- 10.33)	0.05%	( 0.04%)
	Non-site specific necrosis and vascular insufficiency NEC	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.73)	-0.05%	( 0.04%)
	Peripheral vasoconstriction, necrosis and vascular insufficiency	24	( 0.4%)	16	( 0.3%)	1.50	(0.80- 2.78)	0.13%	( 0.10%)
	Decreased and nonspecific blood pressure disorders and shock	37	( 0.6%)	57	( 0.9%)	0.65	(0.44- 0.98)	-0.33%	( 0.16%)
	Vascular hypotensive disorders	37	( 0.6%)	57	( 0.9%)	0.65	(0.44- 0.98)	-0.33%	( 0.16%)
	Embolism and thrombosis	40	( 0.7%)	65	( 1.1%)	0.62	(0.42- 0.91)	-0.41%	( 0.17%)
	Aortic embolism and thrombosis	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Non-site specific embolism and thrombosis	3	( 0.0%)	8	( 0.1%)	0.40	(0.12- 1.32)	-0.08%	( 0.05%)
	Peripheral embolism and thrombosis	37	( 0.6%)	56	( 0.9%)	0.66	(0.44- 1.00)	-0.31%	( 0.16%)
	Vascular disorders NEC	9	( 0.1%)	9	( 0.1%)	1.00	(0.40- 2.52)	0.00%	( 0.07%)
	Peripheral vascular disorders NEC	8	( 0.1%)	8	( 0.1%)	1.00	(0.38- 2.67)	0.00%	( 0.07%)
	Vascular malformations and acquired anomalies	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.98)	0.00%	( 0.02%)
	Vascular haemorrhagic disorders	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.26)	0.03%	( 0.02%)
	Haemorrhages NEC	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.26)	0.03%	( 0.02%)
	Vascular injuries	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	0.00%	( 0.02%)
	Arterial and aortic injuries	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	0.00%	( 0.02%)
	Vascular inflammations	11	( 0.2%)	14	( 0.2%)	0.79	(0.36- 1.72)	-0.05%	( 0.08%)
	Arterial inflammations	5	( 0.1%)	3	( 0.0%)	1.65	(0.41- 6.60)	0.03%	( 0.05%)
	Vasculitides NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.87)	-0.02%	( 0.04%)
	Phlebitis NEC	4	( 0.1%)	8	( 0.1%)	0.51	(0.17- 1.59)	-0.07%	( 0.06%)
	Venous varices	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.32)	0.03%	( 0.03%)
	Varicose veins non-site specific	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.32)	0.03%	( 0.03%)
	Vascular hypertensive disorders	71	( 1.2%)	83	( 1.4%)	0.85	(0.62- 1.17)	-0.20%	( 0.20%)
	Vascular hypertensive disorders NEC	71	( 1.2%)	83	( 1.4%)	0.85	(0.62- 1.17)	-0.20%	( 0.20%)

Vitamin comparison: Fatal or non-fatal serious adverse events in all patients

	MedDRA term	Active vitamins		Placebo vitamins		Risk ratio (95% CI)		Absolute excess (SE)
	Any event	5066	(84.0%)	4996	(82.8%)	1.03	(0.99- 1.07)	1.13%	( 0.68%)
	Blood and lymphatic system disorders	105	( 1.7%)	132	( 2.2%)	0.80	(0.62- 1.03)	-0.45%	( 0.25%)
	Anaemias nonhaemolytic and marrow depression	79	( 1.3%)	100	( 1.7%)	0.79	(0.59- 1.06)	-0.35%	( 0.22%)
	Anaemia deficiencies	25	( 0.4%)	45	( 0.7%)	0.56	(0.35- 0.90)	-0.33%	( 0.14%)
	Anaemias NEC	55	( 0.9%)	56	( 0.9%)	0.98	(0.68- 1.43)	-0.02%	( 0.17%)
	Haematological disorders NEC	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	-0.00%	( 0.03%)
	Haematological disorders	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	-0.00%	( 0.03%)
	Platelet disorders	4	( 0.1%)	14	( 0.2%)	0.33	(0.13- 0.83)	-0.17%	( 0.07%)
	Platelet disorders NEC	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.97)	-0.02%	( 0.05%)
	Thrombocytopenias	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.55)	-0.03%	( 0.04%)
	Thrombocytoses	0	( 0.0%)	5	( 0.1%)	0.14	(0.02- 0.78)	-0.08%	( 0.04%)
	Red blood cell disorders	5	( 0.1%)	6	( 0.1%)	0.84	(0.26- 2.72)	-0.02%	( 0.05%)
	Polycythaemia (excl rubra vera)	5	( 0.1%)	6	( 0.1%)	0.84	(0.26- 2.72)	-0.02%	( 0.05%)
	Spleen, lymphatic and reticuloendothelial system disorders	4	( 0.1%)	0	( 0.0%)	7.40	(1.04- 52.57)	0.07%	( 0.03%)
	Lymphatic system disorders NEC	4	( 0.1%)	0	( 0.0%)	7.40	(1.04- 52.57)	0.07%	( 0.03%)
	White blood cell disorders	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.13)	-0.00%	( 0.03%)
	Neutropenias	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.13)	-0.00%	( 0.03%)
	Coagulopathies and bleeding diatheses (excl thrombocytopenic)	13	( 0.2%)	12	( 0.2%)	1.09	(0.50- 2.38)	0.02%	( 0.08%)
	Coagulopathies	13	( 0.2%)	12	( 0.2%)	1.09	(0.50- 2.38)	0.02%	( 0.08%)
	Cardiac disorders	1775	(29.4%)	1694	(28.1%)	1.06	(0.99- 1.13)	1.33%	( 0.82%)
	Cardiac arrhythmias	318	( 5.3%)	344	( 5.7%)	0.92	(0.79- 1.08)	-0.43%	( 0.41%)
	Cardiac conduction disorders	6	( 0.1%)	5	( 0.1%)	1.20	(0.37- 3.92)	0.02%	( 0.05%)
	Rate and rhythm disorders NEC	129	( 2.1%)	133	( 2.2%)	0.97	(0.76- 1.24)	-0.07%	( 0.27%)
	Supraventricular arrhythmias	179	( 3.0%)	211	( 3.5%)	0.85	(0.70- 1.03)	-0.53%	( 0.32%)
	Ventricular arrhythmias and cardiac arrest	29	( 0.5%)	22	( 0.4%)	1.32	(0.76- 2.28)	0.12%	( 0.12%)
	Cardiac disorder signs and symptoms	46	( 0.8%)	49	( 0.8%)	0.94	(0.63- 1.40)	-0.05%	( 0.16%)
	Cardiac disorders NEC	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.36)	0.03%	( 0.03%)
	Cardiac signs and symptoms NEC	43	( 0.7%)	48	( 0.8%)	0.90	(0.59- 1.35)	-0.08%	( 0.16%)
	Coronary artery disorders	1226	(20.3%)	1165	(19.3%)	1.06	(0.98- 1.15)	1.00%	( 0.73%)
	Coronary artery disorders NEC	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.75)	-0.05%	( 0.04%)
	Ischaemic coronary artery disorders	1225	(20.3%)	1162	(19.3%)	1.07	(0.98- 1.16)	1.04%	( 0.73%)
	Heart failures	260	( 4.3%)	248	( 4.1%)	1.05	(0.88- 1.25)	0.20%	( 0.37%)
	Heart failures NEC	248	( 4.1%)	240	( 4.0%)	1.04	(0.87- 1.24)	0.13%	( 0.36%)
	Left ventricular failures	16	( 0.3%)	10	( 0.2%)	1.59	(0.74- 3.43)	0.10%	( 0.08%)
	Right ventricular failures	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.31)	0.02%	( 0.02%)
	Myocardial disorders	219	( 3.6%)	191	( 3.2%)	1.15	(0.95- 1.39)	0.46%	( 0.33%)
	Cardiomyopathies	216	( 3.6%)	190	( 3.2%)	1.14	(0.94- 1.38)	0.43%	( 0.33%)
	Myocardial disorders NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	-0.00%	( 0.02%)
	Noninfectious myocarditis	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.33)	0.03%	( 0.02%)
	Pericardial disorders	4	( 0.1%)	4	( 0.1%)	1.00	(0.25- 4.01)	-0.00%	( 0.05%)
	Pericardial disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Noninfectious pericarditis	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Cardiac valve disorders	10	( 0.2%)	12	( 0.2%)	0.84	(0.36- 1.93)	-0.03%	( 0.08%)
	Aortic valvular disorders	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.72)	0.02%	( 0.03%)
	Mitral valvular disorders	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.83)	0.02%	( 0.03%)
	Cardiac valve disorders NEC	6	( 0.1%)	10	( 0.2%)	0.61	(0.23- 1.62)	-0.07%	( 0.07%)
	Congenital, familial and genetic disorders	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.55)	-0.03%	( 0.04%)
	Blood and lymphatic system disorders congenital	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Haemoglobinopathies congenital	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Metabolic and nutritional disorders congenital	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.62)	-0.03%	( 0.03%)
	Inborn errors of bilirubin metabolism	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.62)	-0.03%	( 0.03%)
	Reproductive tract and breast disorders congenital	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.60)	0.02%	( 0.02%)
	Male reproductive tract disorders congenital	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.60)	0.02%	( 0.02%)
	Ear and labyrinth disorders	47	( 0.8%)	37	( 0.6%)	1.27	(0.83- 1.95)	0.17%	( 0.15%)
	Hearing disorders	13	( 0.2%)	6	( 0.1%)	2.09	(0.85- 5.15)	0.12%	( 0.07%)
	Hearing losses	13	( 0.2%)	6	( 0.1%)	2.09	(0.85- 5.15)	0.12%	( 0.07%)
	Inner ear and VIIIth cranial nerve disorders	33	( 0.5%)	29	( 0.5%)	1.14	(0.69- 1.88)	0.07%	( 0.13%)
	Inner ear signs and symptoms	31	( 0.5%)	27	( 0.4%)	1.15	(0.69- 1.92)	0.07%	( 0.13%)
	Inner ear disorders NEC	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.96)	-0.00%	( 0.04%)
	Aural disorders NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Ear disorders NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Endocrine disorders	83	( 1.4%)	86	( 1.4%)	0.97	(0.72- 1.31)	-0.05%	( 0.21%)
	Adrenal gland disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Adrenal cortical hyperfunctions	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Thyroid gland disorders	83	( 1.4%)	84	( 1.4%)	0.99	(0.73- 1.34)	-0.02%	( 0.21%)
	Thyroid disorders NEC	14	( 0.2%)	9	( 0.1%)	1.55	(0.68- 3.51)	0.08%	( 0.08%)
	Thyroid hyperfunction disorders	20	( 0.3%)	14	( 0.2%)	1.43	(0.73- 2.80)	0.10%	( 0.10%)
	Thyroid hypofunction disorders	53	( 0.9%)	64	( 1.1%)	0.83	(0.58- 1.19)	-0.18%	( 0.18%)
	Endocrine and glandular disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Endocrine disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Eye disorders	133	( 2.2%)	127	( 2.1%)	1.05	(0.82- 1.34)	0.10%	( 0.26%)
	Eye disorders NEC	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.23)	0.05%	( 0.04%)
	Corneal disorders NEC	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.47)	0.03%	( 0.02%)
	Ocular disorders NEC	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.79)	0.02%	( 0.03%)
	Ocular infections, irritations and inflammations	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.21)	0.05%	( 0.04%)
	Iris and uveal tract infections, irritations and inflammations	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	-0.00%	( 0.02%)
	Ocular infections, inflammations and associated manifestations	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.24)	0.03%	( 0.02%)
	Retinal, choroid and vitreous infections and inflammations	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.32)	0.02%	( 0.02%)
	Ocular structural change, deposit and degeneration NEC	37	( 0.6%)	31	( 0.5%)	1.20	(0.74- 1.92)	0.10%	( 0.14%)
	Retinal structural change, deposit and degeneration	37	( 0.6%)	31	( 0.5%)	1.20	(0.74- 1.92)	0.10%	( 0.14%)
	Retina, choroid and vitreous haemorrhages and vascular disorders	32	( 0.5%)	31	( 0.5%)	1.03	(0.63- 1.70)	0.02%	( 0.13%)
	Retinal bleeding and vascular disorders (excl retinopathy)	14	( 0.2%)	13	( 0.2%)	1.08	(0.51- 2.30)	0.02%	( 0.09%)
	Retinopathies NEC	21	( 0.3%)	20	( 0.3%)	1.05	(0.57- 1.94)	0.02%	( 0.11%)
	Vision disorders	62	( 1.0%)	69	( 1.1%)	0.90	(0.64- 1.27)	-0.12%	( 0.19%)
	Blindness (excl colour blindness)	15	( 0.2%)	16	( 0.3%)	0.94	(0.46- 1.90)	-0.02%	( 0.09%)
	Visual disorders NEC	50	( 0.8%)	53	( 0.9%)	0.95	(0.64- 1.39)	-0.05%	( 0.17%)
	Gastrointestinal disorders	552	( 9.1%)	525	( 8.7%)	1.06	(0.94- 1.20)	0.44%	( 0.52%)
	Abdominal hernias and other abdominal wall conditions	52	( 0.9%)	25	( 0.4%)	2.03	(1.30- 3.17)	0.45%	( 0.14%)
	Abdominal hernias, site unspecified	12	( 0.2%)	3	( 0.0%)	3.33	(1.21- 9.16)	0.15%	( 0.06%)
	Diaphragmatic hernias	41	( 0.7%)	22	( 0.4%)	1.84	(1.12- 3.01)	0.31%	( 0.13%)
	Anal and rectal conditions NEC	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.97)	-0.02%	( 0.05%)
	Anal and rectal disorders NEC	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.97)	-0.02%	( 0.05%)
	Diverticular disorders	1	( 0.0%)	0	( 0.0%)	7.42	(0.15-373.97)	0.02%	( 0.02%)
	Diverticula	1	( 0.0%)	0	( 0.0%)	7.42	(0.15-373.97)	0.02%	( 0.02%)
	Exocrine pancreas conditions	24	( 0.4%)	28	( 0.5%)	0.86	(0.50- 1.48)	-0.07%	( 0.12%)
	Pancreatic disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Acute and chronic pancreatitis	24	( 0.4%)	27	( 0.4%)	0.89	(0.51- 1.54)	-0.05%	( 0.12%)
	Gastrointestinal conditions NEC	103	( 1.7%)	106	( 1.8%)	0.98	(0.74- 1.28)	-0.05%	( 0.24%)
	Gastrointestinal disorders NEC	91	( 1.5%)	93	( 1.5%)	0.98	(0.74- 1.31)	-0.03%	( 0.22%)
	Gastrointestinal fistulae	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.67)	0.02%	( 0.02%)
	Oesophageal disorders NEC	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.68)	0.02%	( 0.02%)
	Gastrointestinal mucosal dystrophies and secretion disorders	11	( 0.2%)	13	( 0.2%)	0.85	(0.38- 1.89)	-0.03%	( 0.08%)
	Gastrointestinal haemorrhages NEC	111	( 1.8%)	100	( 1.7%)	1.11	(0.85- 1.46)	0.18%	( 0.24%)
	Non-site specific gastrointestinal haemorrhages	74	( 1.2%)	71	( 1.2%)	1.05	(0.75- 1.45)	0.05%	( 0.20%)
	Intestinal haemorrhages	38	( 0.6%)	29	( 0.5%)	1.31	(0.81- 2.12)	0.15%	( 0.14%)
	Gastrointestinal inflammatory conditions	55	( 0.9%)	49	( 0.8%)	1.13	(0.77- 1.66)	0.10%	( 0.17%)
	Colitis (excl infective)	24	( 0.4%)	29	( 0.5%)	0.83	(0.48- 1.42)	-0.08%	( 0.12%)
	Gastritis (excl infective)	26	( 0.4%)	19	( 0.3%)	1.37	(0.76- 2.46)	0.12%	( 0.11%)
	Gastrointestinal inflammatory disorders NEC	5	( 0.1%)	1	( 0.0%)	3.81	(0.77- 18.87)	0.07%	( 0.04%)
	Gastrointestinal motility and defaecation conditions	53	( 0.9%)	53	( 0.9%)	1.00	(0.69- 1.47)	-0.00%	( 0.17%)
	Diarrhoea (excl infective)	30	( 0.5%)	22	( 0.4%)	1.36	(0.79- 2.35)	0.13%	( 0.12%)
	Gastrointestinal atonic and hypomotility disorders NEC	20	( 0.3%)	24	( 0.4%)	0.84	(0.46- 1.51)	-0.07%	( 0.11%)
	Gastrointestinal dyskinetic disorders	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.35)	0.02%	( 0.02%)
	Gastrointestinal spastic and hypermotility disorders	2	( 0.0%)	6	( 0.1%)	0.37	(0.09- 1.47)	-0.07%	( 0.05%)
	Non-mechanical ileus	0	( 0.0%)	1	( 0.0%)	0.13	(0.00- 6.80)	-0.02%	( 0.02%)
	Gastrointestinal stenosis and obstruction	13	( 0.2%)	10	( 0.2%)	1.30	(0.58- 2.95)	0.05%	( 0.08%)
	Gastrointestinal stenosis and obstruction NEC	10	( 0.2%)	9	( 0.1%)	1.11	(0.45- 2.74)	0.02%	( 0.07%)
	Oesophageal stenosis and obstruction	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.37)	0.03%	( 0.03%)
	Gastrointestinal signs and symptoms	149	( 2.5%)	152	( 2.5%)	0.98	(0.78- 1.23)	-0.05%	( 0.28%)
	Dyspeptic signs and symptoms	34	( 0.6%)	34	( 0.6%)	1.00	(0.62- 1.61)	-0.00%	( 0.14%)
	Flatulence, bloating and distension	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.18)	-0.03%	( 0.02%)
	Gastrointestinal and abdominal pains (excl oral and throat)	78	( 1.3%)	86	( 1.4%)	0.91	(0.67- 1.23)	-0.13%	( 0.21%)
	Gastrointestinal signs and symptoms NEC	18	( 0.3%)	14	( 0.2%)	1.29	(0.64- 2.57)	0.07%	( 0.09%)
	Nausea and vomiting symptoms	21	( 0.3%)	23	( 0.4%)	0.91	(0.51- 1.65)	-0.03%	( 0.11%)
	Gastrointestinal ulceration and perforation	37	( 0.6%)	45	( 0.7%)	0.82	(0.53- 1.27)	-0.13%	( 0.15%)
	Duodenal ulcers and perforation	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.39)	0.03%	( 0.03%)
	Gastric ulcers and perforation	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Gastrointestinal ulcers and perforation, site unspecified	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Oesophageal ulcers and perforation	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Intestinal ulcers and perforation NEC	2	( 0.0%)	5	( 0.1%)	0.43	(0.10- 1.87)	-0.05%	( 0.04%)
	Peptic ulcers and perforation	31	( 0.5%)	35	( 0.6%)	0.89	(0.55- 1.44)	-0.07%	( 0.13%)
	Gastrointestinal vascular conditions	7	( 0.1%)	5	( 0.1%)	1.41	(0.45- 4.36)	0.03%	( 0.06%)
	Gastrointestinal vascular occlusion and infarction	4	( 0.1%)	2	( 0.0%)	1.97	(0.40- 9.77)	0.03%	( 0.04%)
	Haemorrhoids and gastrointestinal varices (excl oesophageal)	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.09)	0.03%	( 0.02%)
	Oesophageal varices	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.62)	-0.03%	( 0.03%)
	Malabsorption conditions	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.20)	0.05%	( 0.04%)
	Malabsorption syndromes	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.20)	0.05%	( 0.04%)
	Oral soft tissue conditions	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.88)	-0.02%	( 0.04%)
	Stomatitis and ulceration	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.88)	-0.02%	( 0.04%)
	Peritoneal and retroperitoneal conditions	5	( 0.1%)	6	( 0.1%)	0.84	(0.26- 2.73)	-0.02%	( 0.05%)
	Peritoneal and retroperitoneal disorders	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.97)	-0.02%	( 0.05%)
	Peritoneal and retroperitoneal fibrosis and adhesions	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.05)	-0.00%	( 0.02%)
	Dental and gingival conditions	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.70)	0.02%	( 0.02%)
	Dental disorders NEC	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.70)	0.02%	( 0.02%)
	General disorders and administration site conditions	464	( 7.7%)	470	( 7.8%)	0.99	(0.87- 1.12)	-0.10%	( 0.49%)
	Body temperature conditions	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Febrile disorders	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Tissue disorders NEC	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.23)	0.02%	( 0.02%)
	Mass conditions NEC	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.23)	0.02%	( 0.02%)
	General system disorders NEC	452	( 7.5%)	458	( 7.6%)	0.99	(0.87- 1.12)	-0.10%	( 0.48%)
	Asthenic conditions	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.32)	-0.02%	( 0.04%)
	General signs and symptoms NEC	91	( 1.5%)	85	( 1.4%)	1.07	(0.80- 1.44)	0.10%	( 0.22%)
	Hernias NEC	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-372.94)	0.02%	( 0.02%)
	Oedema NEC	43	( 0.7%)	46	( 0.8%)	0.94	(0.62- 1.42)	-0.05%	( 0.16%)
	Pain and discomfort NEC	336	( 5.6%)	342	( 5.7%)	0.98	(0.85- 1.14)	-0.10%	( 0.42%)
	Therapeutic and nontherapeutic effects (excl toxicity)	7	( 0.1%)	11	( 0.2%)	0.64	(0.25- 1.62)	-0.07%	( 0.07%)
	Therapeutic and nontherapeutic responses	7	( 0.1%)	11	( 0.2%)	0.64	(0.25- 1.62)	-0.07%	( 0.07%)
	Hepatobiliary disorders	106	( 1.8%)	96	( 1.6%)	1.11	(0.84- 1.46)	0.17%	( 0.23%)
	Bile duct disorders	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.67)	0.03%	( 0.04%)
	Bile duct infections and inflammations	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Obstructive bile duct disorders (excl neoplasms)	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-372.87)	0.02%	( 0.02%)
	Structural and other bile duct disorders	2	( 0.0%)	0	( 0.0%)	7.42	(0.46-118.62)	0.03%	( 0.02%)
	Gallbladder disorders	94	( 1.6%)	78	( 1.3%)	1.21	(0.90- 1.63)	0.26%	( 0.22%)
	Cholecystitis and cholelithiasis	93	( 1.5%)	77	( 1.3%)	1.21	(0.90- 1.64)	0.26%	( 0.21%)
	Gallbladder disorders NEC	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.96)	-0.02%	( 0.03%)
	Hepatic and hepatobiliary disorders	14	( 0.2%)	20	( 0.3%)	0.70	(0.36- 1.38)	-0.10%	( 0.10%)
	Cholestasis and jaundice	5	( 0.1%)	7	( 0.1%)	0.72	(0.23- 2.23)	-0.03%	( 0.06%)
	Hepatic fibrosis and cirrhosis	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.31)	-0.02%	( 0.04%)
	Hepatocellular damage and hepatitis NEC	2	( 0.0%)	7	( 0.1%)	0.33	(0.09- 1.22)	-0.08%	( 0.05%)
	Hepatic and hepatobiliary disorders NEC	5	( 0.1%)	2	( 0.0%)	2.37	(0.54- 10.42)	0.05%	( 0.04%)
	Immune system disorders	16	( 0.3%)	24	( 0.4%)	0.67	(0.36- 1.25)	-0.13%	( 0.10%)
	Allergic conditions	11	( 0.2%)	22	( 0.4%)	0.51	(0.26- 1.02)	-0.18%	( 0.10%)
	Allergies to foods, food additives, drugs and other chemicals	2	( 0.0%)	11	( 0.2%)	0.25	(0.08- 0.74)	-0.15%	( 0.06%)
	Anaphylactic responses	6	( 0.1%)	6	( 0.1%)	1.00	(0.32- 3.11)	-0.00%	( 0.06%)
	Allergic conditions NEC	3	( 0.0%)	6	( 0.1%)	0.51	(0.14- 1.90)	-0.05%	( 0.05%)
	Immune disorders NEC	5	( 0.1%)	2	( 0.0%)	2.36	(0.54- 10.40)	0.05%	( 0.04%)
	Amyloidoses	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.35)	0.02%	( 0.02%)
	Immune and associated conditions NEC	1	( 0.0%)	0	( 0.0%)	7.42	(0.15-374.15)	0.02%	( 0.02%)
	Acute and chronic sarcoidosis	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.78)	0.02%	( 0.03%)
	Vasculitides	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-372.08)	0.02%	( 0.02%)
	Transplant rejections	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Infections and infestations	848	(14.1%)	868	(14.4%)	0.98	(0.89- 1.07)	-0.34%	( 0.64%)
	Bacterial infectious disorders	14	( 0.2%)	20	( 0.3%)	0.70	(0.36- 1.38)	-0.10%	( 0.10%)
	Bacterial infections NEC	6	( 0.1%)	7	( 0.1%)	0.86	(0.29- 2.55)	-0.02%	( 0.06%)
	Clostridia infections	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.97)	-0.00%	( 0.04%)
	Helicobacter infections	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Legionella infections	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.85)	-0.02%	( 0.02%)
	Listeria infections	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Staphylococcal infections	4	( 0.1%)	7	( 0.1%)	0.58	(0.18- 1.89)	-0.05%	( 0.05%)
	Fungal infectious disorders	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.82)	0.02%	( 0.03%)
	Fungal infections NEC	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.82)	0.02%	( 0.03%)
	Infections - pathogen unspecified	783	(13.0%)	794	(13.2%)	0.99	(0.89- 1.09)	-0.19%	( 0.61%)
	Bone and joint infections	7	( 0.1%)	6	( 0.1%)	1.17	(0.39- 3.47)	0.02%	( 0.06%)
	Cardiac infections	5	( 0.1%)	3	( 0.0%)	1.65	(0.41- 6.61)	0.03%	( 0.05%)
	Central nervous system and spinal infections	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.95)	-0.02%	( 0.03%)
	Dental and oral soft tissue infections	5	( 0.1%)	6	( 0.1%)	0.84	(0.26- 2.72)	-0.02%	( 0.05%)
	Ear infections	28	( 0.5%)	19	( 0.3%)	1.47	(0.83- 2.61)	0.15%	( 0.11%)
	Eye and eyelid infections	22	( 0.4%)	30	( 0.5%)	0.74	(0.43- 1.27)	-0.13%	( 0.12%)
	Abdominal and gastrointestinal infections	92	( 1.5%)	96	( 1.6%)	0.96	(0.72- 1.28)	-0.07%	( 0.23%)
	Infections NEC	11	( 0.2%)	21	( 0.3%)	0.54	(0.27- 1.07)	-0.17%	( 0.09%)
	Lower respiratory tract and lung infections	429	( 7.1%)	461	( 7.6%)	0.93	(0.82- 1.06)	-0.53%	( 0.48%)
	Male reproductive tract infections	7	( 0.1%)	13	( 0.3%)	0.55	(0.23- 1.32)	-0.12%	( 0.09%)
	Sepsis, bacteraemia, viraemia and fungaemia NEC	29	( 0.5%)	26	( 0.4%)	1.12	(0.66- 1.90)	0.05%	( 0.12%)
	Skin structures and soft tissue infections	121	( 2.0%)	101	( 1.7%)	1.20	(0.92- 1.57)	0.33%	( 0.24%)
	Upper respiratory tract infections	4	( 0.1%)	4	( 0.1%)	1.00	(0.25- 4.01)	-0.00%	( 0.05%)
	Urinary tract infections	107	( 1.8%)	101	( 1.7%)	1.06	(0.81- 1.39)	0.10%	( 0.24%)
	Hepatobiliary and spleen infections	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.30)	-0.05%	( 0.03%)
	Mycobacterial infectious disorders	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.12)	-0.00%	( 0.03%)
	Tuberculous infections	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.12)	-0.00%	( 0.03%)
	Viral infectious disorders	63	( 1.0%)	76	( 1.3%)	0.83	(0.60- 1.16)	-0.22%	( 0.19%)
	Herpes viral infections	31	( 0.5%)	37	( 0.6%)	0.84	(0.52- 1.35)	-0.10%	( 0.14%)
	Influenza viral infections	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Viral infections NEC	31	( 0.5%)	36	( 0.6%)	0.86	(0.53- 1.39)	-0.08%	( 0.14%)
	Injury, poisoning and procedural complications	708	(11.7%)	685	(11.4%)	1.04	(0.93- 1.15)	0.38%	( 0.58%)
	Bone and joint injuries	264	( 4.4%)	250	( 4.1%)	1.06	(0.89- 1.26)	0.23%	( 0.37%)
	Lower limb fractures and dislocations	86	( 1.4%)	80	( 1.3%)	1.08	(0.80- 1.46)	0.10%	( 0.21%)
	Fractures and dislocations NEC	73	( 1.2%)	88	( 1.5%)	0.83	(0.61- 1.13)	-0.25%	( 0.21%)
	Pelvic fractures and dislocations	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	-0.00%	( 0.02%)
	Spinal fractures and dislocations	8	( 0.1%)	9	( 0.1%)	0.89	(0.34- 2.30)	-0.02%	( 0.07%)
	Thoracic cage fractures and dislocations	28	( 0.5%)	24	( 0.4%)	1.17	(0.68- 2.01)	0.07%	( 0.12%)
	Upper limb fractures and dislocations	83	( 1.4%)	61	( 1.0%)	1.36	(0.98- 1.89)	0.36%	( 0.20%)
	Injuries NEC	441	( 7.3%)	425	( 7.0%)	1.04	(0.91- 1.19)	0.26%	( 0.47%)
	Chest and lung injuries NEC	12	( 0.2%)	13	( 0.2%)	0.92	(0.42- 2.03)	-0.02%	( 0.08%)
	Eye injuries NEC	3	( 0.0%)	0	( 0.0%)	7.37	(0.77- 70.81)	0.05%	( 0.03%)
	Muscle, tendon and ligament injuries	13	( 0.2%)	10	( 0.2%)	1.30	(0.57- 2.95)	0.05%	( 0.08%)
	Non-site specific injuries NEC	395	( 6.5%)	381	( 6.3%)	1.04	(0.90- 1.20)	0.23%	( 0.45%)
	Site specific injuries NEC	18	( 0.3%)	18	( 0.3%)	1.00	(0.52- 1.93)	-0.00%	( 0.10%)
	Cerebral injuries NEC	11	( 0.2%)	12	( 0.2%)	0.92	(0.41- 2.08)	-0.02%	( 0.08%)
	Injuries by physical agents	4	( 0.1%)	6	( 0.1%)	0.67	(0.19- 2.32)	-0.03%	( 0.05%)
	Thermal burns	4	( 0.1%)	6	( 0.1%)	0.67	(0.19- 2.32)	-0.03%	( 0.05%)
	Medication errors	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.11)	0.03%	( 0.02%)
	Overdoses	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.11)	0.03%	( 0.02%)
	Chemical injury and poisoning	7	( 0.1%)	0	( 0.0%)	7.41	(1.68- 32.60)	0.12%	( 0.04%)
	Chemical injuries	2	( 0.0%)	0	( 0.0%)	7.43	(0.46-118.87)	0.03%	( 0.02%)
	Poisoning and toxicity	5	( 0.1%)	0	( 0.0%)	7.40	(1.28- 42.69)	0.08%	( 0.04%)
	Procedural related injuries and complications NEC	50	( 0.8%)	52	( 0.9%)	0.96	(0.65- 1.42)	-0.03%	( 0.17%)
	Cardiac and vascular procedural complications	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Non-site specific procedural complications	50	( 0.8%)	50	( 0.8%)	1.00	(0.68- 1.48)	-0.00%	( 0.17%)
	Respiratory tract and thoracic cavity procedural complications	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Investigations	1808	(30.0%)	1727	(28.6%)	1.06	(1.00- 1.14)	1.33%	( 0.83%)
	Cardiac and vascular investigations (excl enzyme tests)	795	(13.2%)	778	(12.9%)	1.02	(0.93- 1.13)	0.28%	( 0.61%)
	Cardiac function diagnostic procedures	204	( 3.4%)	201	( 3.3%)	1.02	(0.84- 1.24)	0.05%	( 0.33%)
	Cardiac imaging procedures	593	( 9.8%)	578	( 9.6%)	1.03	(0.92- 1.15)	0.25%	( 0.54%)
	Vascular and lymphatic histopathology procedures	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.35)	0.03%	( 0.03%)
	Vascular imaging procedures NEC	61	( 1.0%)	67	( 1.1%)	0.91	(0.65- 1.29)	-0.10%	( 0.19%)
	Endocrine investigations (incl sex hormones)	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	-0.00%	( 0.02%)
	Endocrine analyses and imaging NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	-0.00%	( 0.02%)
	Enzyme investigations NEC	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.31)	0.03%	( 0.03%)
	Skeletal and cardiac muscle analyses	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.31)	0.03%	( 0.03%)
	Gastrointestinal investigations	530	( 8.8%)	498	( 8.3%)	1.07	(0.95- 1.21)	0.53%	( 0.51%)
	Gastrointestinal and abdominal imaging procedures	530	( 8.8%)	498	( 8.3%)	1.07	(0.95- 1.21)	0.53%	( 0.51%)
	Haematology investigations (incl blood groups)	9	( 0.1%)	14	( 0.2%)	0.65	(0.29- 1.47)	-0.08%	( 0.08%)
	Haematological analyses NEC	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Bone marrow and immune tissue histopathology procedures	8	( 0.1%)	12	( 0.2%)	0.67	(0.28- 1.61)	-0.07%	( 0.07%)
	Hepatobiliary investigations	24	( 0.4%)	10	( 0.2%)	2.28	(1.17- 4.47)	0.23%	( 0.10%)
	Hepatobiliary histopathology procedures	6	( 0.1%)	1	( 0.0%)	4.18	(0.95- 18.38)	0.08%	( 0.04%)
	Hepatobiliary imaging procedures	11	( 0.2%)	4	( 0.1%)	2.55	(0.93- 7.01)	0.12%	( 0.06%)
	Liver function analyses	8	( 0.1%)	5	( 0.1%)	1.59	(0.54- 4.71)	0.05%	( 0.06%)
	Immunology and allergy investigations	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.27)	0.03%	( 0.02%)
	Cell marker procedures	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.27)	0.03%	( 0.02%)
	Investigations, imaging and histopathology procedures NEC	545	( 9.0%)	522	( 8.7%)	1.05	(0.93- 1.19)	0.38%	( 0.52%)
	Histopathology procedures NEC	35	( 0.6%)	40	( 0.7%)	0.88	(0.56- 1.38)	-0.08%	( 0.14%)
	Imaging procedures NEC	35	( 0.6%)	34	( 0.6%)	1.03	(0.64- 1.66)	0.02%	( 0.14%)
	Investigations NEC	489	( 8.1%)	459	( 7.6%)	1.07	(0.95- 1.22)	0.49%	( 0.49%)
	Metabolic, nutritional and blood gas investigations	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.96)	-0.02%	( 0.03%)
	Carbohydrate tolerance analyses (incl diabetes)	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.96)	-0.02%	( 0.03%)
	Musculoskeletal and soft tissue investigations (excl enzyme tests)	12	( 0.2%)	11	( 0.2%)	1.09	(0.48- 2.48)	0.02%	( 0.08%)
	Musculoskeletal and soft tissue histopathology procedures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Musculoskeletal and soft tissue imaging procedures	12	( 0.2%)	10	( 0.2%)	1.20	(0.52- 2.77)	0.03%	( 0.08%)
	Neurological, special senses and psychiatric investigations	8	( 0.1%)	7	( 0.1%)	1.15	(0.42- 3.15)	0.02%	( 0.06%)
	Central nervous system imaging procedures	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.32)	0.03%	( 0.03%)
	Neurologic diagnostic procedures	4	( 0.1%)	6	( 0.1%)	0.67	(0.19- 2.32)	-0.03%	( 0.05%)
	Psychiatric investigations	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-373.07)	0.02%	( 0.02%)
	Renal and urinary tract investigations and urinalyses	167	( 2.8%)	169	( 2.8%)	0.99	(0.80- 1.23)	-0.03%	( 0.30%)
	Urinary tract histopathology procedures	46	( 0.8%)	50	( 0.8%)	0.92	(0.62- 1.37)	-0.07%	( 0.16%)
	Urinary tract imaging procedures	138	( 2.3%)	130	( 2.2%)	1.06	(0.84- 1.35)	0.13%	( 0.27%)
	Reproductive organ and breast investigations (excl hormone analyses)	85	( 1.4%)	75	( 1.2%)	1.14	(0.83- 1.55)	0.17%	( 0.21%)
	Reproductive organ and breast histopathology procedures	79	( 1.3%)	74	( 1.2%)	1.07	(0.78- 1.47)	0.08%	( 0.20%)
	Reproductive organ and breast imaging procedures	6	( 0.6%)	1	( 0.1%)	4.16	(0.95- 18.31)	0.49%	( 0.26%)
	Respiratory and pulmonary investigations (excl blood gases)	68	( 1.1%)	93	( 1.5%)	0.73	(0.54- 1.00)	-0.41%	( 0.21%)
	Respiratory tract and thoracic histopathology procedures	24	( 0.4%)	30	( 0.5%)	0.80	(0.47- 1.37)	-0.10%	( 0.12%)
	Respiratory tract and thoracic imaging procedures	43	( 0.7%)	69	( 1.1%)	0.63	(0.43- 0.91)	-0.43%	( 0.17%)
	Respiratory and pulmonary function diagnostic procedures	6	( 0.1%)	3	( 0.0%)	1.95	(0.53- 7.22)	0.05%	( 0.05%)
	Physical examination topics	9	( 0.1%)	11	( 0.2%)	0.82	(0.34- 1.97)	-0.03%	( 0.07%)
	Physical examination procedures	9	( 0.1%)	11	( 0.2%)	0.82	(0.34- 1.97)	-0.03%	( 0.07%)
	Metabolism and nutrition disorders	718	(11.9%)	688	(11.4%)	1.05	(0.94- 1.16)	0.49%	( 0.58%)
	Appetite and general nutritional disorders	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.68)	0.03%	( 0.04%)
	General nutritional disorders NEC	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.68)	0.03%	( 0.04%)
	Diabetic complications	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Diabetic complications NEC	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.87)	0.02%	( 0.04%)
	Electrolyte and fluid balance conditions	34	( 0.6%)	28	( 0.5%)	1.22	(0.74- 2.00)	0.10%	( 0.13%)
	Electrolyte imbalance NEC	9	( 0.1%)	7	( 0.1%)	1.29	(0.48- 3.43)	0.03%	( 0.07%)
	Total fluid volume decreased	26	( 0.4%)	21	( 0.3%)	1.24	(0.70- 2.20)	0.08%	( 0.11%)
	Glucose metabolism disorders (incl diabetes mellitus)	652	(10.8%)	630	(10.4%)	1.04	(0.93- 1.16)	0.36%	( 0.56%)
	Diabetes mellitus (incl subtypes)	644	(10.7%)	616	(10.2%)	1.05	(0.94- 1.17)	0.46%	( 0.56%)
	Hypoglycaemic conditions NEC	11	( 0.2%)	18	( 0.3%)	0.62	(0.30- 1.28)	-0.12%	( 0.09%)
	Purine and pyrimidine metabolism disorders	34	( 0.6%)	37	( 0.6%)	0.92	(0.58- 1.47)	-0.05%	( 0.14%)
	Disorders of purine metabolism	34	( 0.6%)	37	( 0.6%)	0.92	(0.58- 1.47)	-0.05%	( 0.14%)
	Musculoskeletal and connective tissue disorders	416	( 6.9%)	390	( 6.5%)	1.07	(0.93- 1.23)	0.43%	( 0.45%)
	Bone disorders (excl congenital and fractures)	24	( 0.4%)	23	( 0.4%)	1.05	(0.59- 1.85)	0.02%	( 0.11%)
	Metabolic bone disorders	21	( 0.3%)	20	( 0.3%)	1.05	(0.57- 1.94)	0.02%	( 0.11%)
	Bone disorders NEC	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.96)	-0.00%	( 0.04%)
	Connective tissue disorders (excl congenital)	31	( 0.5%)	16	( 0.3%)	1.90	(1.07- 3.37)	0.25%	( 0.11%)
	Connective tissue disorders (excl LE)	29	( 0.5%)	15	( 0.2%)	1.90	(1.05- 3.42)	0.23%	( 0.11%)
	Lupus erythematosus (incl subtypes)	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.78)	0.02%	( 0.03%)
	Synovial and bursal disorders	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.68)	0.03%	( 0.04%)
	Bursal disorders	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.13)	-0.00%	( 0.03%)
	Synovial disorders	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.22)	0.03%	( 0.02%)
	Fractures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Pathological fractures and complications	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Joint disorders	159	( 2.6%)	139	( 2.3%)	1.15	(0.92- 1.44)	0.33%	( 0.28%)
	Arthropathies NEC	66	( 1.1%)	67	( 1.1%)	0.99	(0.70- 1.39)	-0.02%	( 0.19%)
	Joint related signs and symptoms	7	( 0.1%)	11	( 0.2%)	0.64	(0.26- 1.62)	-0.07%	( 0.07%)
	Psoriatic arthropathies	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Rheumatoid arthropathies	39	( 0.6%)	29	( 0.5%)	1.35	(0.84- 2.17)	0.17%	( 0.14%)
	Spondyloarthropathies	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.33)	0.02%	( 0.02%)
	Osteoarthropathies	50	( 0.8%)	42	( 0.7%)	1.19	(0.79- 1.80)	0.13%	( 0.16%)
	Muscle disorders	98	( 1.6%)	106	( 1.8%)	0.93	(0.70- 1.22)	-0.13%	( 0.23%)
	Muscle infections and inflammations	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.29)	0.02%	( 0.02%)
	Muscle pains	69	( 1.1%)	71	( 1.2%)	0.97	(0.70- 1.36)	-0.03%	( 0.20%)
	Muscle related signs and symptoms NEC	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.32)	-0.02%	( 0.04%)
	Myopathies	23	( 0.4%)	32	( 0.5%)	0.72	(0.43- 1.22)	-0.15%	( 0.12%)
	Muscle weakness conditions	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.17)	0.03%	( 0.02%)
	Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)	5	( 0.1%)	4	( 0.1%)	1.25	(0.34- 4.62)	0.02%	( 0.05%)
	Spine and neck deformities	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Intervertebral disc disorders NEC	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.67)	0.03%	( 0.04%)
	Musculoskeletal and connective tissue disorders NEC	119	( 2.0%)	119	( 2.0%)	1.00	(0.78- 1.29)	-0.00%	( 0.25%)
	Musculoskeletal and connective tissue signs and symptoms NEC	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.49)	0.03%	( 0.02%)
	Musculoskeletal and connective tissue infections and inflammations NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Musculoskeletal and connective tissue pain and discomfort	117	( 1.9%)	118	( 2.0%)	1.00	(0.77- 1.28)	-0.02%	( 0.25%)
	Tendon, ligament and cartilage disorders	7	( 0.1%)	2	( 0.0%)	3.05	(0.82- 11.26)	0.08%	( 0.05%)
	Cartilage disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Tendon disorders	7	( 0.1%)	1	( 0.0%)	4.50	(1.12- 17.99)	0.10%	( 0.05%)
	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	904	(15.0%)	875	(14.5%)	1.04	(0.94- 1.14)	0.48%	( 0.65%)
	Breast neoplasms malignant and unspecified (incl nipple)	22	( 0.4%)	32	( 0.5%)	0.69	(0.41- 1.18)	-0.17%	( 0.12%)
	Breast and nipple neoplasms malignant	22	( 0.4%)	32	( 0.5%)	0.69	(0.41- 1.18)	-0.17%	( 0.12%)
	Endocrine neoplasms benign	7	( 0.1%)	0	( 0.0%)	7.42	(1.69- 32.67)	0.12%	( 0.04%)
	Adrenal neoplasms benign	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.42)	0.03%	( 0.02%)
	Endocrine neoplasms benign NEC	5	( 0.1%)	0	( 0.0%)	7.43	(1.29- 42.87)	0.08%	( 0.04%)
	Endocrine neoplasms malignant and unspecified	1	( 0.0%)	5	( 0.1%)	0.26	(0.05- 1.31)	-0.07%	( 0.04%)
	Carcinoid tumours	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Endocrine neoplasms malignant and unspecified NEC	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.31)	-0.05%	( 0.03%)
	Thyroid neoplasms malignant	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.93)	-0.02%	( 0.03%)
	Gastrointestinal neoplasms benign	5	( 0.1%)	8	( 0.1%)	0.63	(0.21- 1.87)	-0.05%	( 0.06%)
	Lip and oral cavity neoplasms benign	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Lower gastrointestinal neoplasms benign	5	( 0.1%)	6	( 0.1%)	0.84	(0.26- 2.73)	-0.02%	( 0.05%)
	Gastrointestinal neoplasms malignant and unspecified	149	( 2.5%)	153	( 2.5%)	0.98	(0.78- 1.22)	-0.07%	( 0.28%)
	Colonic neoplasms malignant	67	( 1.1%)	62	( 1.0%)	1.08	(0.77- 1.53)	0.08%	( 0.19%)
	Colorectal and anal neoplasms malignancy unspecified	22	( 0.4%)	34	( 0.6%)	0.65	(0.39- 1.10)	-0.20%	( 0.12%)
	Gastric neoplasms malignant	20	( 0.3%)	25	( 0.4%)	0.80	(0.45- 1.44)	-0.08%	( 0.11%)
	Gastrointestinal neoplasms malignant NEC	2	( 0.0%)	5	( 0.1%)	0.43	(0.10- 1.87)	-0.05%	( 0.04%)
	Lip and oral cavity neoplasms malignant	11	( 0.2%)	4	( 0.1%)	2.55	(0.93- 7.01)	0.12%	( 0.06%)
	Oesophageal neoplasms malignant	20	( 0.3%)	17	( 0.3%)	1.18	(0.62- 2.25)	0.05%	( 0.10%)
	Pancreatic neoplasms malignant (excl islet cell and carcinoid)	12	( 0.2%)	11	( 0.2%)	1.09	(0.48- 2.48)	0.02%	( 0.08%)
	Rectal neoplasms malignant	5	( 0.1%)	11	( 0.2%)	0.47	(0.18- 1.26)	-0.10%	( 0.07%)
	Salivary gland neoplasms malignant	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.30)	-0.05%	( 0.03%)
	Small intestinal neoplasms malignant	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-373.12)	0.02%	( 0.02%)
	Haematopoietic neoplasms (excl leukaemias and lymphomas)	9	( 0.1%)	11	( 0.2%)	0.82	(0.34- 1.97)	-0.03%	( 0.07%)
	Haematologic neoplasms NEC	9	( 0.1%)	11	( 0.2%)	0.82	(0.34- 1.97)	-0.03%	( 0.07%)
	Hepatobiliary neoplasms malignant and unspecified	13	( 0.2%)	13	( 0.2%)	1.00	(0.46- 2.16)	-0.00%	( 0.08%)
	Bile duct neoplasms malignant	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	-0.00%	( 0.02%)
	Gallbladder neoplasms malignant	6	( 0.1%)	7	( 0.1%)	0.86	(0.29- 2.55)	-0.02%	( 0.06%)
	Hepatic neoplasms malignant	7	( 0.1%)	5	( 0.1%)	1.40	(0.45- 4.34)	0.03%	( 0.06%)
	Hepatobiliary neoplasms malignancy unspecified	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.32)	0.02%	( 0.02%)
	Hepatobiliary neoplasms malignant NEC	2	( 0.0%)	4	( 0.1%)	0.52	(0.10- 2.55)	-0.03%	( 0.04%)
	Leukaemias	33	( 0.5%)	35	( 0.6%)	0.94	(0.59- 1.52)	-0.03%	( 0.14%)
	Leukaemias acute lymphocytic	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.81)	0.02%	( 0.03%)
	Leukaemias acute myeloid	4	( 0.1%)	2	( 0.0%)	1.95	(0.39- 9.67)	0.03%	( 0.04%)
	Leukaemias chronic lymphocytic	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.79)	0.02%	( 0.03%)
	Leukaemias myeloid NEC	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.41)	0.02%	( 0.02%)
	Leukaemias NEC	22	( 0.4%)	23	( 0.4%)	0.96	(0.53- 1.72)	-0.02%	( 0.11%)
	Myelodysplastic syndromes	11	( 0.2%)	13	( 0.2%)	0.85	(0.38- 1.89)	-0.03%	( 0.08%)
	Lymphomas Hodgkin's disease	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.31)	-0.02%	( 0.04%)
	Hodgkin's disease NEC	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.31)	-0.02%	( 0.04%)
	Lymphomas non-Hodgkin's B-cell	4	( 0.1%)	1	( 0.0%)	3.37	(0.58- 19.44)	0.05%	( 0.04%)
	B-cell lymphomas NEC	3	( 0.0%)	0	( 0.0%)	7.55	(0.78- 72.57)	0.05%	( 0.03%)
	B-cell small lymphocytic lymphomas	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.06)	-0.00%	( 0.02%)
	Lymphomas non-Hodgkin's unspecified histology	19	( 0.3%)	16	( 0.3%)	1.19	(0.61- 2.31)	0.05%	( 0.10%)
	Non-Hodgkin's lymphomas NEC	19	( 0.3%)	16	( 0.3%)	1.19	(0.61- 2.31)	0.05%	( 0.10%)
	Lymphomas NEC	5	( 0.1%)	9	( 0.1%)	0.57	(0.20- 1.61)	-0.07%	( 0.06%)
	Lymphomas unspecified NEC	5	( 0.1%)	9	( 0.1%)	0.57	(0.20- 1.61)	-0.07%	( 0.06%)
	Mesotheliomas	10	( 0.2%)	5	( 0.1%)	1.96	(0.71- 5.38)	0.08%	( 0.06%)
	Mesotheliomas malignant and unspecified	10	( 0.2%)	5	( 0.1%)	1.96	(0.71- 5.38)	0.08%	( 0.06%)
	Metastases	11	( 0.2%)	9	( 0.1%)	1.22	(0.51- 2.94)	0.03%	( 0.07%)
	Metastases to unknown and unspecified sites	11	( 0.2%)	9	( 0.1%)	1.22	(0.51- 2.94)	0.03%	( 0.07%)
	Miscellaneous and site unspecified neoplasms malignant and unspecified	14	( 0.2%)	12	( 0.2%)	1.17	(0.54- 2.52)	0.03%	( 0.08%)
	Neoplasms malignant site unspecified NEC	12	( 0.2%)	12	( 0.2%)	1.00	(0.45- 2.23)	-0.00%	( 0.08%)
	Neoplasms unspecified malignancy and site unspecified NEC	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.22)	0.03%	( 0.02%)
	Miscellaneous and site unspecified neoplasms benign	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Aural neoplasms benign	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Nervous system neoplasms benign	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.99)	-0.00%	( 0.02%)
	Nervous system neoplasms benign NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Neuromas	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.54)	0.02%	( 0.02%)
	Nervous system neoplasms malignant and unspecified NEC	12	( 0.2%)	6	( 0.1%)	1.95	(0.78- 4.92)	0.10%	( 0.07%)
	Central nervous system neoplasms malignant NEC	12	( 0.2%)	5	( 0.1%)	2.28	(0.88- 5.91)	0.12%	( 0.07%)
	Nervous system neoplasms unspecified malignancy NEC	1	( 0.0%)	1	( 0.0%)	1.01	(0.06- 16.07)	-0.00%	( 0.02%)
	Pineal neoplasms	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Plasma cell neoplasms	8	( 0.1%)	11	( 0.2%)	0.73	(0.30- 1.80)	-0.05%	( 0.07%)
	Multiple myelomas	8	( 0.1%)	10	( 0.2%)	0.80	(0.32- 2.02)	-0.03%	( 0.07%)
	Plasma cell neoplasms NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.85)	-0.02%	( 0.02%)
	Renal and urinary tract neoplasms malignant and unspecified	95	( 1.6%)	85	( 1.4%)	1.12	(0.84- 1.50)	0.17%	( 0.22%)
	Bladder neoplasms malignant	65	( 1.1%)	66	( 1.1%)	0.99	(0.70- 1.39)	-0.02%	( 0.19%)
	Renal pelvis and ureter neoplasms malignant	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.50)	0.03%	( 0.02%)
	Urinary tract neoplasms malignant NEC	2	( 0.0%)	0	( 0.0%)	7.43	(0.46-118.79)	0.03%	( 0.02%)
	Renal neoplasms malignant	30	( 0.5%)	20	( 0.3%)	1.50	(0.86- 2.60)	0.17%	( 0.12%)
	Reproductive neoplasms female malignant and unspecified	11	( 1.1%)	8	( 0.8%)	1.35	(0.55- 3.33)	0.29%	( 0.42%)
	Cervix neoplasms malignant	3	( 0.3%)	0	( 0.0%)	7.33	(0.76- 70.43)	0.29%	( 0.17%)
	Endometrial neoplasms malignant	2	( 0.2%)	5	( 0.5%)	0.42	(0.10- 1.84)	-0.29%	( 0.26%)
	Female reproductive neoplasms unspecified malignancy	2	( 0.2%)	2	( 0.2%)	0.99	(0.14- 7.00)	-0.00%	( 0.19%)
	Ovarian neoplasms malignant (excl germ cell)	6	( 0.6%)	3	( 0.3%)	1.92	(0.52- 7.10)	0.29%	( 0.29%)
	Uterine neoplasms malignant NEC	1	( 0.1%)	1	( 0.1%)	0.99	(0.06- 15.83)	-0.00%	( 0.14%)
	Reproductive neoplasms female benign	1	( 0.1%)	1	( 0.1%)	1.00	(0.06- 15.99)	-0.00%	( 0.14%)
	Uterine neoplasms benign	1	( 0.1%)	1	( 0.1%)	1.00	(0.06- 15.99)	-0.00%	( 0.14%)
	Reproductive neoplasms male malignant and unspecified	164	( 3.3%)	146	( 2.9%)	1.13	(0.91- 1.41)	0.36%	( 0.35%)
	Penile neoplasms malignant	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.04%	( 0.03%)
	Prostatic neoplasms malignant	163	( 3.3%)	143	( 2.9%)	1.15	(0.92- 1.44)	0.40%	( 0.34%)
	Reproductive neoplasms male unspecified malignancy	17	( 0.3%)	19	( 0.4%)	0.90	(0.47- 1.73)	-0.04%	( 0.12%)
	Respiratory and mediastinal neoplasms malignant and unspecified	146	( 2.4%)	147	( 2.4%)	1.00	(0.79- 1.25)	-0.02%	( 0.28%)
	Laryngeal neoplasms malignant	6	( 0.1%)	7	( 0.1%)	0.86	(0.29- 2.55)	-0.02%	( 0.06%)
	Mediastinal neoplasms malignancy unspecified NEC	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.40)	0.03%	( 0.02%)
	Oropharyngeal, nasopharyngeal and tonsillar neoplasms malignant and unspecified	3	( 0.0%)	2	( 0.0%)	1.50	(0.26- 8.65)	0.02%	( 0.04%)
	Respiratory tract and pleural neoplasms malignant cell type unspecified NEC	135	( 2.2%)	139	( 2.3%)	0.97	(0.77- 1.23)	-0.07%	( 0.27%)
	Respiratory tract and pleural neoplasms malignancy unspecified NEC	4	( 0.1%)	0	( 0.0%)	7.43	(1.05- 52.72)	0.07%	( 0.03%)
	Cutaneous neoplasms benign	7	( 0.1%)	12	( 0.2%)	0.59	(0.24- 1.45)	-0.08%	( 0.07%)
	Skin neoplasms benign	7	( 0.1%)	12	( 0.2%)	0.59	(0.24- 1.45)	-0.08%	( 0.07%)
	Skin neoplasms malignant and unspecified	262	( 4.3%)	263	( 4.4%)	1.00	(0.84- 1.19)	-0.02%	( 0.37%)
	Skin melanomas (excl ocular)	32	( 0.5%)	27	( 0.4%)	1.19	(0.71- 1.98)	0.08%	( 0.13%)
	Skin neoplasms malignant and unspecified (excl melanoma)	242	( 4.0%)	246	( 4.1%)	0.99	(0.83- 1.18)	-0.07%	( 0.36%)
	Soft tissue neoplasms benign	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.79)	0.02%	( 0.03%)
	Soft tissue neoplasms benign NEC	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.79)	0.02%	( 0.03%)
	Soft tissue sarcomas	10	( 0.2%)	2	( 0.0%)	3.80	(1.22- 11.77)	0.13%	( 0.06%)
	Fibrosarcomas malignant	10	( 0.2%)	2	( 0.0%)	3.80	(1.22- 11.77)	0.13%	( 0.06%)
	Neoplasm related morbidities	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.44)	0.02%	( 0.02%)
	Oncologic complications and emergencies	1	( 0.0%)	0	( 0.0%)	7.41	(0.15-373.44)	0.02%	( 0.02%)
	Nervous system disorders	684	(11.3%)	678	(11.2%)	1.01	(0.91- 1.13)	0.10%	( 0.58%)
	Central nervous system infections and inflammations	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.50)	0.03%	( 0.02%)
	Encephalitis NEC	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.50)	0.03%	( 0.02%)
	Central nervous system vascular disorders	365	( 6.1%)	386	( 6.4%)	0.95	(0.82- 1.09)	-0.35%	( 0.44%)
	Central nervous system haemorrhages and cerebrovascular accidents	261	( 4.3%)	258	( 4.3%)	1.01	(0.85- 1.21)	0.05%	( 0.37%)
	Central nervous system vascular disorders NEC	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.97)	-0.02%	( 0.05%)
	Transient cerebrovascular events	129	( 2.1%)	162	( 2.7%)	0.80	(0.63- 1.00)	-0.55%	( 0.28%)
	Cranial nerve disorders (excl neoplasms)	5	( 0.1%)	10	( 0.2%)	0.51	(0.19- 1.42)	-0.08%	( 0.06%)
	Cranial nerve disorders NEC	2	( 0.0%)	4	( 0.1%)	0.51	(0.10- 2.55)	-0.03%	( 0.04%)
	Facial cranial nerve disorders	3	( 0.0%)	6	( 0.1%)	0.52	(0.14- 1.90)	-0.05%	( 0.05%)
	Vagus nerve disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Demyelinating disorders	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Multiple sclerosis acute and progressive	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Encephalopathies	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.41)	0.02%	( 0.02%)
	Encephalopathies NEC	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.41)	0.02%	( 0.02%)
	Headaches	31	( 0.5%)	24	( 0.4%)	1.29	(0.76- 2.19)	0.12%	( 0.12%)
	Headaches NEC	26	( 0.4%)	21	( 0.3%)	1.24	(0.70- 2.20)	0.08%	( 0.11%)
	Migraine headaches	6	( 0.1%)	3	( 0.0%)	1.95	(0.53- 7.21)	0.05%	( 0.05%)
	Increased intracranial pressure and hydrocephalus	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.54)	0.03%	( 0.02%)
	Hydrocephalic conditions	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.54)	0.03%	( 0.02%)
	Movement disorders (incl parkinsonism)	36	( 0.6%)	22	( 0.4%)	1.63	(0.97- 2.72)	0.23%	( 0.13%)
	Paralysis and paresis (excl cranial nerve)	1	( 0.0%)	0	( 0.0%)	7.38	(0.15-371.88)	0.02%	( 0.02%)
	Parkinson's disease and parkinsonism	33	( 0.5%)	20	( 0.3%)	1.64	(0.96- 2.81)	0.22%	( 0.12%)
	Tremor (excl congenital)	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.96)	-0.00%	( 0.04%)
	Neurological disorders NEC	187	( 3.1%)	178	( 3.0%)	1.06	(0.86- 1.30)	0.15%	( 0.31%)
	Cerebellar coordination and balance disturbances	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Disturbances in consciousness NEC	114	( 1.9%)	100	( 1.7%)	1.14	(0.88- 1.50)	0.23%	( 0.24%)
	Neurological signs and symptoms NEC	69	( 1.1%)	70	( 1.2%)	0.99	(0.71- 1.38)	-0.02%	( 0.19%)
	Sensory abnormalities NEC	7	( 0.1%)	8	( 0.1%)	0.88	(0.32- 2.41)	-0.02%	( 0.06%)
	Coma states	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.74)	0.02%	( 0.03%)
	Nervous system disorders NEC	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	-0.00%	( 0.02%)
	Neuromuscular disorders	10	( 0.2%)	5	( 0.1%)	1.95	(0.71- 5.37)	0.08%	( 0.06%)
	Motor neurone diseases	6	( 0.1%)	5	( 0.1%)	1.20	(0.37- 3.92)	0.02%	( 0.05%)
	Neuromuscular junction dysfunction	4	( 0.1%)	0	( 0.0%)	7.41	(1.04- 52.60)	0.07%	( 0.03%)
	Peripheral neuropathies	20	( 0.3%)	27	( 0.4%)	0.74	(0.42- 1.32)	-0.12%	( 0.11%)
	Acute polyneuropathies	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.95)	-0.02%	( 0.03%)
	Mononeuropathies	14	( 0.2%)	16	( 0.3%)	0.88	(0.43- 1.80)	-0.03%	( 0.09%)
	Peripheral neuropathies NEC	5	( 0.1%)	11	( 0.2%)	0.47	(0.18- 1.26)	-0.10%	( 0.07%)
	Seizures (incl subtypes)	18	( 0.3%)	29	( 0.5%)	0.63	(0.35- 1.11)	-0.18%	( 0.11%)
	Seizures and seizure disorders NEC	18	( 0.3%)	29	( 0.5%)	0.63	(0.35- 1.11)	-0.18%	( 0.11%)
	Sleep disturbances (incl subtypes)	1	( 0.0%)	0	( 0.0%)	7.42	(0.15-373.99)	0.02%	( 0.02%)
	Narcolepsy and hypersomnia	1	( 0.0%)	0	( 0.0%)	7.42	(0.15-373.99)	0.02%	( 0.02%)
	Spinal cord and nerve root disorders	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.89)	-0.02%	( 0.04%)
	Spinal cord and nerve root disorders NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.89)	-0.02%	( 0.04%)
	Mental impairment disorders	53	( 0.9%)	52	( 0.9%)	1.02	(0.70- 1.50)	0.02%	( 0.17%)
	Alzheimer's disease (incl subtypes)	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Dementia (excl Alzheimer's type)	49	( 0.8%)	43	( 0.7%)	1.14	(0.76- 1.72)	0.10%	( 0.16%)
	Memory loss (excl dementia)	4	( 0.1%)	8	( 0.1%)	0.52	(0.17- 1.60)	-0.07%	( 0.06%)
	Psychiatric disorders	79	( 1.3%)	77	( 1.3%)	1.03	(0.75- 1.41)	0.03%	( 0.21%)
	Anxiety disorders and symptoms	20	( 0.3%)	15	( 0.2%)	1.33	(0.69- 2.59)	0.08%	( 0.10%)
	Anxiety symptoms	4	( 0.1%)	5	( 0.1%)	0.80	(0.22- 2.96)	-0.02%	( 0.05%)
	Anxiety disorders NEC	16	( 0.3%)	10	( 0.2%)	1.59	(0.74- 3.43)	0.10%	( 0.08%)
	Deliria (incl confusion)	3	( 0.0%)	7	( 0.1%)	0.45	(0.13- 1.56)	-0.07%	( 0.05%)
	Confusion and disorientation	3	( 0.0%)	7	( 0.1%)	0.45	(0.13- 1.56)	-0.07%	( 0.05%)
	Depressed mood disorders and disturbances	53	( 0.9%)	48	( 0.8%)	1.11	(0.75- 1.63)	0.08%	( 0.17%)
	Depressive disorders	53	( 0.9%)	48	( 0.8%)	1.11	(0.75- 1.63)	0.08%	( 0.17%)
	Psychiatric disorders NEC	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.69)	0.02%	( 0.02%)
	Substance-related disorders	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.69)	0.02%	( 0.02%)
	Schizophrenia and other psychotic disorders	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Psychotic disorder NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Sexual dysfunctions, disturbances and gender identity disorders	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Sexual desire disorders	1	( 0.0%)	4	( 0.1%)	0.30	(0.05- 1.74)	-0.05%	( 0.04%)
	Sleep disorders and disturbances	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Disturbances in initiating and maintaining sleep	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Suicidal and self-injurious behaviours NEC	7	( 0.1%)	5	( 0.1%)	1.40	(0.45- 4.34)	0.03%	( 0.06%)
	Suicidal and self-injurious behaviour	7	( 0.1%)	5	( 0.1%)	1.40	(0.45- 4.34)	0.03%	( 0.06%)
	Renal and urinary disorders	186	( 3.1%)	154	( 2.6%)	1.21	(0.98- 1.50)	0.53%	( 0.30%)
	Bladder and bladder neck disorders (excl calculi)	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.87)	-0.02%	( 0.02%)
	Bladder disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.87)	-0.02%	( 0.02%)
	Genitourinary tract disorders NEC	3	( 0.0%)	0	( 0.0%)	7.42	(0.77- 71.32)	0.05%	( 0.03%)
	Genital and urinary tract disorders NEC	3	( 0.0%)	0	( 0.0%)	7.42	(0.77- 71.32)	0.05%	( 0.03%)
	Nephropathies	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.94)	-0.02%	( 0.03%)
	Glomerulonephritis and nephrotic syndrome	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.25)	0.02%	( 0.02%)
	Nephritis NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.83)	-0.02%	( 0.02%)
	Nephropathies and tubular disorders NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Renal disorders (excl nephropathies)	65	( 1.1%)	63	( 1.0%)	1.04	(0.73- 1.47)	0.03%	( 0.19%)
	Renal disorders NEC	3	( 0.0%)	4	( 0.1%)	0.75	(0.17- 3.32)	-0.02%	( 0.04%)
	Renal failure and impairment	58	( 1.0%)	58	( 1.0%)	1.00	(0.70- 1.45)	-0.00%	( 0.18%)
	Renal neoplasms	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.35)	0.03%	( 0.03%)
	Renal obstructive disorders	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.47)	0.03%	( 0.02%)
	Renal vascular and ischaemic conditions	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	-0.00%	( 0.02%)
	Urethral disorders (excl calculi)	16	( 0.3%)	20	( 0.3%)	0.80	(0.42- 1.54)	-0.07%	( 0.10%)
	Structural and obstructive urethral disorders (excl congenital)	16	( 0.3%)	20	( 0.3%)	0.80	(0.42- 1.54)	-0.07%	( 0.10%)
	Urinary tract signs and symptoms	66	( 1.1%)	37	( 0.6%)	1.76	(1.20- 2.59)	0.48%	( 0.17%)
	Urinary abnormalities	20	( 0.3%)	10	( 0.2%)	1.95	(0.95- 4.00)	0.17%	( 0.09%)
	Bladder and urethral symptoms	29	( 0.5%)	13	( 0.2%)	2.15	(1.17- 3.93)	0.27%	( 0.11%)
	Urinary tract signs and symptoms NEC	18	( 0.3%)	15	( 0.2%)	1.20	(0.61- 2.38)	0.05%	( 0.10%)
	Urolithiases	40	( 0.7%)	38	( 0.6%)	1.06	(0.68- 1.64)	0.03%	( 0.15%)
	Urinary tract lithiasis (excl renal)	40	( 0.7%)	38	( 0.6%)	1.06	(0.68- 1.64)	0.03%	( 0.15%)
	Reproductive system and breast disorders	60	( 1.0%)	61	( 1.0%)	0.99	(0.69- 1.41)	-0.02%	( 0.18%)
	Breast disorders	5	( 0.1%)	6	( 0.1%)	0.83	(0.26- 2.72)	-0.02%	( 0.05%)
	Breast disorders NEC	5	( 0.1%)	6	( 0.1%)	0.83	(0.26- 2.72)	-0.02%	( 0.05%)
	Penile and scrotal disorders (excl infections and inflammations)	2	( 0.0%)	3	( 0.1%)	0.67	(0.12- 3.89)	-0.02%	( 0.04%)
	Penile disorders NEC (excl erection and ejaculation)	2	( 0.0%)	3	( 0.1%)	0.67	(0.12- 3.89)	-0.02%	( 0.04%)
	Testicular and epididymal disorders	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.96)	-0.02%	( 0.03%)
	Testicular and epididymal disorders NEC	1	( 0.0%)	2	( 0.0%)	0.52	(0.05- 4.96)	-0.02%	( 0.03%)
	Ovarian and fallopian tube disorders	2	( 0.2%)	0	( 0.0%)	7.29	(0.46-116.50)	0.19%	( 0.14%)
	Ovarian and fallopian tube cysts and neoplasms	2	( 0.2%)	0	( 0.0%)	7.29	(0.46-116.50)	0.19%	( 0.14%)
	Prostatic disorders (excl infections and inflammations)	44	( 0.9%)	45	( 0.9%)	0.98	(0.65- 1.49)	-0.02%	( 0.19%)
	Prostatic signs, symptoms and disorders NEC	44	( 0.9%)	45	( 0.9%)	0.98	(0.65- 1.49)	-0.02%	( 0.19%)
	Reproductive tract disorders NEC	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.69)	0.02%	( 0.02%)
	Reproductive tract disorders NEC (excl neoplasms)	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.69)	0.02%	( 0.02%)
	Uterine, pelvic and broad ligament disorders	0	( 0.0%)	3	( 0.3%)	0.13	(0.01- 1.29)	-0.29%	( 0.17%)
	Pelvic prolapse conditions	0	( 0.0%)	3	( 0.0%)	0.14	(0.01- 1.31)	-0.05%	( 0.03%)
	Vulvovaginal disorders (excl infections and inflammations)	5	( 0.5%)	2	( 0.2%)	2.34	(0.53- 10.31)	0.29%	( 0.26%)
	Vulvovaginal disorders NEC	5	( 0.5%)	2	( 0.2%)	2.34	(0.53- 10.31)	0.29%	( 0.26%)
	Respiratory, thoracic and mediastinal disorders	461	( 7.6%)	447	( 7.4%)	1.04	(0.91- 1.18)	0.23%	( 0.48%)
	Bronchial disorders (excl neoplasms)	86	( 1.4%)	77	( 1.3%)	1.12	(0.82- 1.52)	0.15%	( 0.21%)
	Bronchial conditions NEC	6	( 0.1%)	5	( 0.1%)	1.20	(0.37- 3.92)	0.02%	( 0.05%)
	Bronchospasm and obstruction	80	( 1.3%)	72	( 1.2%)	1.11	(0.81- 1.53)	0.13%	( 0.20%)
	Thoracic disorders (excl lung and pleura)	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.21)	0.05%	( 0.04%)
	Mediastinal disorders	4	( 0.1%)	1	( 0.0%)	3.33	(0.58- 19.21)	0.05%	( 0.04%)
	Lower respiratory tract disorders (excl obstruction and infection)	43	( 0.7%)	57	( 0.9%)	0.76	(0.51- 1.12)	-0.23%	( 0.17%)
	Lower respiratory tract inflammatory and immunologic conditions	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.88)	-0.02%	( 0.04%)
	Parenchymal lung disorders NEC	42	( 0.7%)	54	( 0.9%)	0.78	(0.52- 1.16)	-0.20%	( 0.16%)
	Pleural disorders	66	( 1.1%)	44	( 0.7%)	1.50	(1.03- 2.17)	0.36%	( 0.17%)
	Pleural infections and inflammations	34	( 0.6%)	18	( 0.3%)	1.86	(1.08- 3.20)	0.27%	( 0.12%)
	Pneumothorax and pleural effusions NEC	34	( 0.6%)	26	( 0.4%)	1.31	(0.79- 2.17)	0.13%	( 0.13%)
	Pulmonary vascular disorders	51	( 0.8%)	59	( 1.0%)	0.87	(0.60- 1.26)	-0.13%	( 0.17%)
	Pulmonary thrombotic and embolic conditions	51	( 0.8%)	59	( 1.0%)	0.87	(0.60- 1.26)	-0.13%	( 0.17%)
	Respiratory disorders NEC	193	( 3.2%)	191	( 3.2%)	1.01	(0.83- 1.24)	0.03%	( 0.32%)
	Breathing abnormalities	171	( 2.8%)	167	( 2.8%)	1.03	(0.83- 1.27)	0.07%	( 0.30%)
	Coughing and associated symptoms	15	( 0.2%)	17	( 0.3%)	0.88	(0.44- 1.77)	-0.03%	( 0.09%)
	Lower respiratory tract signs and symptoms	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	-0.00%	( 0.02%)
	Respiratory signs and symptoms NEC	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.61)	-0.03%	( 0.03%)
	Upper respiratory tract signs and symptoms	4	( 0.1%)	3	( 0.0%)	1.33	(0.30- 5.86)	0.02%	( 0.04%)
	Respiratory failures (excl neonatal)	1	( 0.0%)	0	( 0.0%)	7.44	(0.15-374.93)	0.02%	( 0.02%)
	Respiratory tract disorders NEC	3	( 0.0%)	3	( 0.0%)	1.00	(0.20- 4.97)	-0.00%	( 0.04%)
	Upper respiratory tract disorders (excl infections)	55	( 0.9%)	53	( 0.9%)	1.04	(0.71- 1.52)	0.03%	( 0.17%)
	Nasal disorders NEC	51	( 0.8%)	52	( 0.9%)	0.98	(0.67- 1.45)	-0.02%	( 0.17%)
	Nasal congestion and inflammations	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.41)	0.03%	( 0.02%)
	Pharyngeal disorders (excl infections and neoplasms)	2	( 0.0%)	1	( 0.0%)	1.95	(0.20- 18.79)	0.02%	( 0.03%)
	Skin and subcutaneous tissue disorders	181	( 3.0%)	219	( 3.6%)	0.83	(0.68- 1.01)	-0.63%	( 0.33%)
	Angioedema and urticaria	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.98)	-0.00%	( 0.02%)
	Urticarias	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 15.98)	-0.00%	( 0.02%)
	Cornification and dystrophic skin disorders	8	( 0.1%)	10	( 0.2%)	0.80	(0.32- 2.02)	-0.03%	( 0.07%)
	Skin preneoplastic conditions NEC	8	( 0.1%)	10	( 0.2%)	0.80	(0.32- 2.02)	-0.03%	( 0.07%)
	Epidermal and dermal conditions	140	( 2.3%)	178	( 3.0%)	0.79	(0.63- 0.98)	-0.63%	( 0.29%)
	Bullous conditions	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	-0.00%	( 0.02%)
	Connective tissue disorders	2	( 0.0%)	0	( 0.0%)	7.39	(0.46-118.14)	0.03%	( 0.02%)
	Dermal and epidermal conditions NEC	89	( 1.5%)	107	( 1.8%)	0.83	(0.63- 1.10)	-0.30%	( 0.23%)
	Dermatitis and eczema	21	( 0.3%)	22	( 0.4%)	0.96	(0.53- 1.74)	-0.02%	( 0.11%)
	Skin injuries and mechanical dermatoses	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	-0.00%	( 0.02%)
	Pruritus NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Rashes, eruptions and exanthems NEC	23	( 0.4%)	44	( 0.7%)	0.54	(0.33- 0.86)	-0.35%	( 0.14%)
	Psoriatic conditions	5	( 0.1%)	5	( 0.1%)	1.00	(0.29- 3.46)	-0.00%	( 0.05%)
	Pigmentation disorders	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.18)	-0.03%	( 0.02%)
	Pigmentation changes NEC	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.18)	-0.03%	( 0.02%)
	Skin and subcutaneous tissue disorders NEC	24	( 0.4%)	22	( 0.4%)	1.09	(0.61- 1.95)	0.03%	( 0.11%)
	Skin and subcutaneous tissue ulcerations	24	( 0.4%)	21	( 0.3%)	1.15	(0.64- 2.05)	0.05%	( 0.11%)
	Skin and subcutaneous malformations and anomalies NEC	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.86)	-0.02%	( 0.02%)
	Skin appendage conditions	9	( 0.1%)	13	( 0.2%)	0.70	(0.30- 1.61)	-0.07%	( 0.08%)
	Apocrine and eccrine gland disorders	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	-0.00%	( 0.03%)
	Nail and nail bed conditions (excl infections and infestations)	5	( 0.1%)	11	( 0.2%)	0.47	(0.18- 1.26)	-0.10%	( 0.07%)
	Pilar disorders NEC	2	( 0.0%)	0	( 0.0%)	7.43	(0.46-118.83)	0.03%	( 0.02%)
	Social circumstances	6	( 0.1%)	3	( 0.0%)	1.95	(0.53- 7.21)	0.05%	( 0.05%)
	Legal issues	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.34)	0.03%	( 0.03%)
	Criminal activity	3	( 0.0%)	1	( 0.0%)	2.72	(0.38- 19.34)	0.03%	( 0.03%)
	Lifestyle issues	3	( 0.0%)	2	( 0.0%)	1.50	(0.26- 8.63)	0.02%	( 0.04%)
	Alcohol product use	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	-0.00%	( 0.02%)
	Disability issues	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Social issues NEC	2	( 0.0%)	0	( 0.0%)	7.40	(0.46-118.31)	0.03%	( 0.02%)
	Surgical and medical procedures	2582	(42.8%)	2533	(42.0%)	1.03	(0.97- 1.08)	0.80%	( 0.90%)
	Vascular therapeutic procedures	769	(12.7%)	756	(12.5%)	1.03	(0.93- 1.13)	0.21%	( 0.61%)
	Aortic therapeutic procedures	54	( 0.9%)	55	( 0.9%)	0.98	(0.68- 1.43)	-0.02%	( 0.17%)
	Arterial therapeutic procedures (excl aortic)	650	(10.8%)	640	(10.6%)	1.02	(0.92- 1.14)	0.16%	( 0.56%)
	Vascular therapeutic procedures NEC	62	( 1.0%)	57	( 0.9%)	1.09	(0.76- 1.56)	0.08%	( 0.18%)
	Venous therapeutic procedures	25	( 0.4%)	32	( 0.5%)	0.78	(0.47- 1.32)	-0.12%	( 0.12%)
	Bone and joint therapeutic procedures	569	( 9.4%)	550	( 9.1%)	1.04	(0.92- 1.17)	0.31%	( 0.53%)
	Bone therapeutic procedures NEC	7	( 0.1%)	9	( 0.1%)	0.78	(0.29- 2.08)	-0.03%	( 0.07%)
	Joint therapeutic procedures	457	( 7.6%)	424	( 7.0%)	1.08	(0.95- 1.24)	0.54%	( 0.47%)
	Limb therapeutic procedures	121	( 2.0%)	139	( 2.3%)	0.87	(0.68- 1.11)	-0.30%	( 0.26%)
	Fracture treatments (excl skull and spine)	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.81)	-0.02%	( 0.02%)
	Breast therapeutic procedures	11	( 0.2%)	12	( 0.2%)	0.92	(0.41- 2.08)	-0.02%	( 0.08%)
	Mastectomies	9	( 0.1%)	6	( 0.1%)	1.49	(0.54- 4.11)	0.05%	( 0.06%)
	Breast therapeutic procedures NEC	3	( 0.0%)	6	( 0.1%)	0.51	(0.14- 1.90)	-0.05%	( 0.05%)
	Cardiac therapeutic procedures	252	( 4.2%)	230	( 3.8%)	1.10	(0.92- 1.31)	0.36%	( 0.36%)
	Cardiac device therapeutic procedures	185	( 3.1%)	161	( 2.7%)	1.15	(0.93- 1.42)	0.40%	( 0.30%)
	Cardiac valve therapeutic procedures	21	( 0.3%)	20	( 0.3%)	1.05	(0.57- 1.94)	0.02%	( 0.11%)
	Cardiac therapeutic procedures NEC	70	( 1.2%)	60	( 1.0%)	1.17	(0.83- 1.65)	0.17%	( 0.19%)
	Nervous system, skull and spine therapeutic procedures	72	( 1.2%)	74	( 1.2%)	0.98	(0.71- 1.35)	-0.03%	( 0.20%)
	Autonomic nerve therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.68)	0.02%	( 0.02%)
	Peripheral nerve therapeutic procedures	21	( 0.3%)	28	( 0.5%)	0.75	(0.43- 1.32)	-0.12%	( 0.12%)
	Skull and brain therapeutic procedures	5	( 0.1%)	4	( 0.1%)	1.25	(0.34- 4.63)	0.02%	( 0.05%)
	Spine and spinal cord therapeutic procedures	47	( 0.8%)	43	( 0.7%)	1.10	(0.73- 1.66)	0.07%	( 0.16%)
	Endocrine gland therapeutic procedures	7	( 0.1%)	6	( 0.1%)	1.17	(0.39- 3.47)	0.02%	( 0.06%)
	Hormonal therapeutic procedures NEC	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.11)	-0.00%	( 0.03%)
	Parathyroid gland therapeutic procedures	2	( 0.0%)	1	( 0.0%)	1.96	(0.20- 18.80)	0.02%	( 0.03%)
	Pituitary and hypothalamic therapeutic procedures	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.47)	0.03%	( 0.02%)
	Thyroid therapeutic procedures	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.61)	-0.03%	( 0.03%)
	Eye therapeutic procedures	445	( 7.4%)	461	( 7.6%)	0.96	(0.85- 1.10)	-0.27%	( 0.48%)
	Eyelid therapeutic procedures	20	( 0.3%)	27	( 0.4%)	0.74	(0.42- 1.32)	-0.12%	( 0.11%)
	Lacrimal apparatus therapeutic procedures	13	( 0.2%)	12	( 0.2%)	1.09	(0.50- 2.38)	0.02%	( 0.08%)
	Lens therapeutic procedures	383	( 6.3%)	392	( 6.5%)	0.98	(0.85- 1.12)	-0.15%	( 0.45%)
	Eye therapeutic procedures NEC	40	( 0.7%)	47	( 0.8%)	0.85	(0.56- 1.30)	-0.12%	( 0.15%)
	Orbit and globe therapeutic procedures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Retinal therapeutic procedures	10	( 0.2%)	5	( 0.1%)	1.96	(0.71- 5.38)	0.08%	( 0.06%)
	Gastrointestinal therapeutic procedures	450	( 7.5%)	409	( 6.8%)	1.11	(0.97- 1.26)	0.68%	( 0.47%)
	Anorectal therapeutic procedures	54	( 0.9%)	56	( 0.9%)	0.97	(0.66- 1.40)	-0.03%	( 0.17%)
	Gastric therapeutic procedures	7	( 0.1%)	5	( 0.1%)	1.40	(0.45- 4.34)	0.03%	( 0.06%)
	Gastrointestinal therapeutic procedures NEC	52	( 0.9%)	33	( 0.5%)	1.57	(1.03- 2.40)	0.31%	( 0.15%)
	Hernia repairs	285	( 4.7%)	244	( 4.0%)	1.17	(0.99- 1.39)	0.68%	( 0.37%)
	Large intestine therapeutic procedures	54	( 0.9%)	72	( 1.2%)	0.75	(0.53- 1.07)	-0.30%	( 0.19%)
	Abdominal therapeutic procedures NEC	12	( 0.2%)	4	( 0.1%)	2.73	(1.02- 7.26)	0.13%	( 0.07%)
	Oesophageal therapeutic procedures	10	( 0.2%)	11	( 0.2%)	0.91	(0.39- 2.14)	-0.02%	( 0.08%)
	Pancreatic therapeutic procedures	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.03)	-0.00%	( 0.02%)
	Small intestine therapeutic procedures	1	( 0.0%)	5	( 0.1%)	0.27	(0.05- 1.31)	-0.07%	( 0.04%)
	Head and neck therapeutic procedures	128	( 2.1%)	119	( 2.0%)	1.08	(0.84- 1.38)	0.15%	( 0.26%)
	Dental and gingival therapeutic procedures	27	( 0.4%)	28	( 0.5%)	0.97	(0.57- 1.64)	-0.02%	( 0.12%)
	Facial therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.39	(0.15-372.54)	0.02%	( 0.02%)
	Laryngeal therapeutic procedures	8	( 0.1%)	11	( 0.2%)	0.73	(0.30- 1.79)	-0.05%	( 0.07%)
	Nasal therapeutic procedures	44	( 0.7%)	41	( 0.7%)	1.07	(0.70- 1.64)	0.05%	( 0.15%)
	Paranasal therapeutic procedures	15	( 0.2%)	16	( 0.3%)	0.94	(0.46- 1.90)	-0.02%	( 0.09%)
	Pharyngeal therapeutic procedures	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.03%	( 0.02%)
	Salivary gland therapeutic procedures	9	( 0.1%)	7	( 0.1%)	1.29	(0.48- 3.43)	0.03%	( 0.07%)
	Tongue therapeutic procedures	7	( 0.1%)	7	( 0.1%)	1.00	(0.35- 2.86)	-0.00%	( 0.06%)
	Head, neck and oral cavity therapeutic procedures NEC	20	( 0.3%)	19	( 0.3%)	1.06	(0.56- 1.98)	0.02%	( 0.10%)
	Hepatobiliary therapeutic procedures	70	( 1.2%)	73	( 1.2%)	0.96	(0.69- 1.33)	-0.05%	( 0.20%)
	Biliary tract and gallbladder therapeutic procedures	70	( 1.2%)	72	( 1.2%)	0.97	(0.70- 1.35)	-0.03%	( 0.20%)
	Hepatic therapeutic procedures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Haematological and lymphoid tissue therapeutic procedures	34	( 0.6%)	57	( 0.9%)	0.60	(0.40- 0.91)	-0.38%	( 0.16%)
	Blood and blood product treatment	27	( 0.4%)	43	( 0.7%)	0.63	(0.40- 1.01)	-0.27%	( 0.14%)
	Lymphoid tissue therapeutic procedures	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.02)	-0.00%	( 0.02%)
	Haematological therapeutic procedures NEC	7	( 0.1%)	15	( 0.2%)	0.48	(0.21- 1.12)	-0.13%	( 0.08%)
	Male genital tract therapeutic procedures	170	( 3.4%)	190	( 3.8%)	0.90	(0.73- 1.10)	-0.40%	( 0.37%)
	Epididymal therapeutic procedures	5	( 0.1%)	5	( 0.1%)	1.00	(0.29- 3.47)	0.00%	( 0.06%)
	Penile therapeutic procedures	23	( 0.5%)	26	( 0.5%)	0.89	(0.51- 1.56)	-0.06%	( 0.14%)
	Prostatic therapeutic procedures	124	( 2.5%)	137	( 2.7%)	0.91	(0.71- 1.16)	-0.26%	( 0.32%)
	Male genital tract therapeutic procedures NEC	4	( 0.1%)	1	( 0.0%)	3.34	(0.58- 19.28)	0.06%	( 0.04%)
	Testicular and scrotal therapeutic procedures	18	( 0.4%)	25	( 0.5%)	0.72	(0.40- 1.32)	-0.14%	( 0.13%)
	Obstetric and gynaecological therapeutic procedures	50	( 4.9%)	47	( 4.6%)	1.06	(0.71- 1.57)	0.28%	( 0.94%)
	Cervix therapeutic procedures	17	( 1.7%)	5	( 0.5%)	2.96	(1.29- 6.84)	1.17%	( 0.45%)
	Ovarian therapeutic procedures	1	( 0.1%)	0	( 0.0%)	7.32	(0.15-369.08)	0.10%	( 0.10%)
	Uterine therapeutic procedures	22	( 2.1%)	22	( 2.1%)	0.99	(0.55- 1.79)	-0.00%	( 0.64%)
	Vaginal therapeutic procedures	14	( 1.4%)	20	( 2.0%)	0.69	(0.35- 1.35)	-0.59%	( 0.56%)
	Renal and urinary tract therapeutic procedures	106	( 1.8%)	111	( 1.8%)	0.96	(0.73- 1.25)	-0.08%	( 0.24%)
	Bladder therapeutic procedures	18	( 0.3%)	31	( 0.5%)	0.59	(0.34- 1.03)	-0.22%	( 0.12%)
	Renal therapeutic procedures	41	( 0.7%)	39	( 0.6%)	1.05	(0.68- 1.63)	0.03%	( 0.15%)
	Therapeutic bladder catheterisation	48	( 0.8%)	47	( 0.8%)	1.02	(0.69- 1.53)	0.02%	( 0.16%)
	Urethral therapeutic procedures	1	( 0.0%)	0	( 0.0%)	7.43	(0.15-374.39)	0.02%	( 0.02%)
	Respiratory tract therapeutic procedures	9	( 0.1%)	10	( 0.2%)	0.90	(0.37- 2.22)	-0.02%	( 0.07%)
	Bronchial and pulmonary therapeutic procedures	9	( 0.1%)	4	( 0.1%)	2.17	(0.73- 6.42)	0.08%	( 0.06%)
	Chest wall and mediastinal therapeutic procedures	1	( 0.0%)	3	( 0.0%)	0.37	(0.05- 2.62)	-0.03%	( 0.03%)
	Pleural therapeutic procedures	1	( 0.0%)	2	( 0.0%)	0.51	(0.05- 4.95)	-0.02%	( 0.03%)
	Tracheal therapeutic procedures	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.82)	-0.02%	( 0.02%)
	Skin and subcutaneous tissue therapeutic procedures	105	( 1.7%)	97	( 1.6%)	1.09	(0.82- 1.43)	0.13%	( 0.23%)
	Nail therapeutic procedures	10	( 0.2%)	13	( 0.2%)	0.77	(0.34- 1.75)	-0.05%	( 0.08%)
	Skin and subcutaneous tissue therapeutic procedures NEC	8	( 0.1%)	5	( 0.1%)	1.59	(0.54- 4.72)	0.05%	( 0.06%)
	Skin grafts	7	( 0.1%)	7	( 0.1%)	1.00	(0.35- 2.86)	-0.00%	( 0.06%)
	Skin lesion excisions	82	( 1.4%)	73	( 1.2%)	1.13	(0.82- 1.54)	0.15%	( 0.21%)
	Soft tissue therapeutic procedures	51	( 0.8%)	48	( 0.8%)	1.06	(0.72- 1.58)	0.05%	( 0.16%)
	Fascial and bursal therapeutic procedures	30	( 0.5%)	31	( 0.5%)	0.97	(0.59- 1.60)	-0.02%	( 0.13%)
	Tendon therapeutic procedures	19	( 0.3%)	15	( 0.2%)	1.27	(0.65- 2.48)	0.07%	( 0.10%)
	Soft tissue therapeutic procedures NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.88)	-0.02%	( 0.04%)
	Therapeutic procedures and supportive care NEC	289	( 4.8%)	290	( 4.8%)	1.00	(0.85- 1.17)	-0.02%	( 0.39%)
	Anaesthesia and allied procedures	76	( 1.3%)	98	( 1.6%)	0.78	(0.58- 1.05)	-0.37%	( 0.22%)
	Analgesia supportive care	2	( 0.0%)	2	( 0.0%)	1.00	(0.14- 7.13)	-0.00%	( 0.03%)
	Chemotherapies	52	( 0.9%)	50	( 0.8%)	1.04	(0.71- 1.54)	0.03%	( 0.17%)
	Therapeutic procedures NEC	123	( 2.0%)	104	( 1.7%)	1.19	(0.91- 1.54)	0.31%	( 0.25%)
	Phototherapies	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Radiotherapies site unspecified	54	( 0.9%)	49	( 0.8%)	1.11	(0.75- 1.63)	0.08%	( 0.17%)
	Drug withdrawal therapies	1	( 0.0%)	0	( 0.0%)	7.40	(0.15-373.05)	0.02%	( 0.02%)
	Dietary and nutritional therapies	1	( 0.0%)	1	( 0.0%)	1.00	(0.06- 16.04)	-0.00%	( 0.02%)
	Vascular disorders	282	( 4.7%)	293	( 4.9%)	0.96	(0.82- 1.13)	-0.18%	( 0.39%)
	Aneurysms and artery dissections	63	( 1.0%)	70	( 1.2%)	0.90	(0.64- 1.27)	-0.12%	( 0.19%)
	Aneurysms and dissections non-site specific	0	( 0.0%)	4	( 0.1%)	0.14	(0.02- 0.97)	-0.07%	( 0.03%)
	Aortic aneurysms and dissections	58	( 1.0%)	67	( 1.1%)	0.87	(0.61- 1.23)	-0.15%	( 0.18%)
	Peripheral aneurysms and dissections	7	( 0.1%)	2	( 0.0%)	3.04	(0.82- 11.25)	0.08%	( 0.05%)
	Arteriosclerosis, stenosis, vascular insufficiency and necrosis	26	( 0.4%)	26	( 0.4%)	1.01	(0.58- 1.73)	-0.00%	( 0.12%)
	Aortic necrosis and vascular insufficiency	4	( 0.1%)	3	( 0.0%)	1.35	(0.31- 5.96)	0.02%	( 0.04%)
	Non-site specific necrosis and vascular insufficiency NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.89)	-0.02%	( 0.04%)
	Peripheral vasoconstriction, necrosis and vascular insufficiency	20	( 0.3%)	20	( 0.3%)	1.00	(0.54- 1.86)	-0.00%	( 0.10%)
	Decreased and nonspecific blood pressure disorders and shock	52	( 0.9%)	42	( 0.7%)	1.24	(0.83- 1.86)	0.17%	( 0.16%)
	Vascular hypotensive disorders	52	( 0.9%)	42	( 0.7%)	1.24	(0.83- 1.86)	0.17%	( 0.16%)
	Embolism and thrombosis	54	( 0.9%)	51	( 0.8%)	1.06	(0.72- 1.56)	0.05%	( 0.17%)
	Aortic embolism and thrombosis	0	( 0.0%)	1	( 0.0%)	0.14	(0.00- 6.84)	-0.02%	( 0.02%)
	Non-site specific embolism and thrombosis	7	( 0.1%)	4	( 0.1%)	1.73	(0.53- 5.65)	0.05%	( 0.05%)
	Peripheral embolism and thrombosis	47	( 0.8%)	46	( 0.8%)	1.02	(0.68- 1.54)	0.02%	( 0.16%)
	Vascular disorders NEC	6	( 0.1%)	12	( 0.2%)	0.51	(0.20- 1.30)	-0.10%	( 0.07%)
	Peripheral vascular disorders NEC	6	( 0.1%)	10	( 0.2%)	0.61	(0.23- 1.62)	-0.07%	( 0.07%)
	Vascular malformations and acquired anomalies	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.16)	-0.03%	( 0.02%)
	Vascular haemorrhagic disorders	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.50)	0.03%	( 0.02%)
	Haemorrhages NEC	2	( 0.0%)	0	( 0.0%)	7.41	(0.46-118.50)	0.03%	( 0.02%)
	Vascular injuries	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Arterial and aortic injuries	0	( 0.0%)	2	( 0.0%)	0.14	(0.01- 2.17)	-0.03%	( 0.02%)
	Vascular inflammations	12	( 0.2%)	13	( 0.2%)	0.93	(0.42- 2.03)	-0.02%	( 0.08%)
	Arterial inflammations	4	( 0.1%)	4	( 0.1%)	1.00	(0.25- 4.01)	-0.00%	( 0.05%)
	Vasculitides NEC	2	( 0.0%)	3	( 0.0%)	0.67	(0.12- 3.88)	-0.02%	( 0.04%)
	Phlebitis NEC	6	( 0.1%)	6	( 0.1%)	1.00	(0.32- 3.11)	-0.00%	( 0.06%)
	Venous varices	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.35)	0.03%	( 0.03%)
	Varicose veins non-site specific	3	( 0.0%)	1	( 0.0%)	2.73	(0.38- 19.35)	0.03%	( 0.03%)
	Vascular hypertensive disorders	69	( 1.1%)	85	( 1.4%)	0.81	(0.59- 1.11)	-0.27%	( 0.20%)
	Vascular hypertensive disorders NEC	69	( 1.1%)	85	( 1.4%)	0.81	(0.59- 1.11)	-0.27%	( 0.20%)