Effectiveness and Safety of Ramipril Alone Compared With Telmisartan Alone and in Combination With Ramipril in Patients at High Risk for Cardiovascular Events. Patients Intolerant to Ramipril Were Entered in TRANSCEND, Telmisartan Compared to Placebo. - Study Results

Study Type:	Interventional
Study Design:	Parallel Assignment
Condition:	Cardiovascular Diseases
Interventions:	Drug: Telmisartan Drug: Combination of Telmisartan and Ramipril Drug: Ramipril

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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	Telmisartan/Ramipril (ONTARGET)	Telmisartan (ONTARGET)	Ramipril (ONTARGET)	Telmisartan (TRANSCEND)	Placebo (TRANSCEND)
STARTED	8502	8542	8576	2954	2972
COMPLETED	8485	8524	8561	2946	2962
NOT COMPLETED	17	18	15	8	10
Lost to Follow-up	14	14	12	5	5
Withdrawal by Subject	3	4	3	3	5

	Telmisartan/Ramipril (ONTARGET)	Telmisartan (ONTARGET)	Ramipril (ONTARGET)	Telmisartan (TRANSCEND)	Placebo (TRANSCEND)	Total
Number of Participants [units: participants]	8502	8542	8576	2954	2972	31546
Age [units: years] Mean ± Standard Deviation	66.4 ± 7.3	66.4 ± 7.1	66.4 ± 7.2	66.9 ± 7.3	66.9 ± 7.4	66.5 ± 7.2
Gender [units: participants]
Female	2250	2250	2331	1280	1267	9378
Male	6252	6292	6245	1674	1705	22168

Serious Adverse Events

Time Frame	No text entered.
Additional Description	No text entered.

Reporting Groups

	Description
Telmisartan/Ramipril (ONTARGET)	Telmisartan 80mg tablet / Ramipril 10mg tablet One tablet of each at the same time daily
Telmisartan (ONTARGET)	Telmisatan 80mg tablet /Ramipril 10mg placebo tablet One tablet of each at the same time daily
Ramipril (ONTARGET)	Ramipril 10mg tablet / Telmisartan 80mg placebo tablet One tablet of each at the same time daily
Telmisartan (TRANSCEND)	Telmisartan 80mg tablet one tablet daily
Placebo (TRANSCEND)	Telmisartan 80mg placebo tablet one tablet daily

Serious Adverse Events

	Telmisartan/Ramipril (ONTARGET)	Telmisartan (ONTARGET)	Ramipril (ONTARGET)	Telmisartan (TRANSCEND)	Placebo (TRANSCEND)
Total, serious adverse events
# participants affected	5733	5807	5687	1905	1936
Blood and lymphatic system disorders
Agranulocytosis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Anaemia ^†^A # participants affected / at risk	170/8502 (2.00%)	189/8542 (2.21%)	155/8576 (1.81%)	48/2954 (1.62%)	43/2972 (1.45%)
Anaemia haemolytic autoimmune ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Anaemia macrocytic ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Anaemia of chronic disease ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Anaemia vitamin B12 deficiency ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Aplastic anaemia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Autoimmune thrombocytopenia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Bone marrow disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Bone marrow failure ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Coagulopathy ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Disseminated intravascular coagulation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Febrile bone marrow aplasia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Febrile neutropenia ^†^A # participants affected / at risk	5/8502 (0.06%)	1/8542 (0.01%)	2/8576 (0.02%)	2/2954 (0.07%)	0/2972 (0.00%)
Haemolysis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Haemolytic anaemia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Haemorrhagic anaemia ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Haemorrhagic diathesis ^†^A # participants affected / at risk	3/8502 (0.04%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Haemorrhagic disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hyperglobulinaemia ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hypersplenism ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Hypochromic anaemia ^†^A # participants affected / at risk	3/8502 (0.04%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Idiopathic thrombocytopenic purpura ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Iron deficiency anaemia ^†^A # participants affected / at risk	2/8502 (0.02%)	7/8542 (0.08%)	8/8576 (0.09%)	4/2954 (0.14%)	2/2972 (0.07%)
Leukocytosis ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	5/8576 (0.06%)	1/2954 (0.03%)	0/2972 (0.00%)
Leukopenia ^†^A # participants affected / at risk	3/8502 (0.04%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Lymphadenopathy ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Lymphadenopathy mediastinal ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Microcytic anaemia ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Nephrogenic anaemia ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Neutropenia ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Normochromic normocytic anaemia ^†^A # participants affected / at risk	4/8502 (0.05%)	3/8542 (0.04%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pancytopenia ^†^A # participants affected / at risk	10/8502 (0.12%)	2/8542 (0.02%)	2/8576 (0.02%)	1/2954 (0.03%)	1/2972 (0.03%)
Pernicious anaemia ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Polycythaemia ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Red blood cell abnormality ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Spleen disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Splenic vein thrombosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Thrombocytopenia ^†^A # participants affected / at risk	11/8502 (0.13%)	4/8542 (0.05%)	3/8576 (0.03%)	3/2954 (0.10%)	1/2972 (0.03%)
Thrombocytopenic purpura ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Cardiac disorders
AV dissociation ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Acute coronary syndrome ^†^A # participants affected / at risk	6/8502 (0.07%)	12/8542 (0.14%)	9/8576 (0.10%)	2/2954 (0.07%)	3/2972 (0.10%)
Acute left ventricular failure ^†^A # participants affected / at risk	0/8502 (0.00%)	5/8542 (0.06%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Acute myocardial infarction ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Adams-Stokes syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Angina pectoris ^†^A # participants affected / at risk	1435/8502 (16.88%)	1460/8542 (17.09%)	1407/8576 (16.41%)	479/2954 (16.22%)	527/2972 (17.73%)
Angina unstable ^†^A # participants affected / at risk	7/8502 (0.08%)	16/8542 (0.19%)	15/8576 (0.17%)	1/2954 (0.03%)	5/2972 (0.17%)
Aortic valve disease ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	3/8576 (0.03%)	0/2954 (0.00%)	0/2972 (0.00%)
Aortic valve incompetence ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Aortic valve stenosis ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	5/8576 (0.06%)	1/2954 (0.03%)	0/2972 (0.00%)
Arrhythmia ^†^A # participants affected / at risk	3/8502 (0.04%)	4/8542 (0.05%)	7/8576 (0.08%)	0/2954 (0.00%)	2/2972 (0.07%)
Arrhythmia supraventricular ^†^A # participants affected / at risk	45/8502 (0.53%)	47/8542 (0.55%)	48/8576 (0.56%)	21/2954 (0.71%)	20/2972 (0.67%)
Arteriosclerosis coronary artery ^†^A # participants affected / at risk	4/8502 (0.05%)	2/8542 (0.02%)	2/8576 (0.02%)	2/2954 (0.07%)	0/2972 (0.00%)
Arteriospasm coronary ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Atrial fibrillation ^†^A # participants affected / at risk	556/8502 (6.54%)	566/8542 (6.63%)	579/8576 (6.75%)	171/2954 (5.79%)	179/2972 (6.02%)
Atrial flutter ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Atrial thrombosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Atrioventricular block ^†^A # participants affected / at risk	6/8502 (0.07%)	6/8542 (0.07%)	9/8576 (0.10%)	3/2954 (0.10%)	2/2972 (0.07%)
Atrioventricular block complete ^†^A # participants affected / at risk	20/8502 (0.24%)	19/8542 (0.22%)	12/8576 (0.14%)	3/2954 (0.10%)	3/2972 (0.10%)
Atrioventricular block first degree ^†^A # participants affected / at risk	3/8502 (0.04%)	0/8542 (0.00%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Atrioventricular block second degree ^†^A # participants affected / at risk	5/8502 (0.06%)	7/8542 (0.08%)	6/8576 (0.07%)	1/2954 (0.03%)	2/2972 (0.07%)
Bifascicular block ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Bradyarrhythmia ^†^A # participants affected / at risk	5/8502 (0.06%)	2/8542 (0.02%)	3/8576 (0.03%)	2/2954 (0.07%)	2/2972 (0.07%)
Bradycardia ^†^A # participants affected / at risk	39/8502 (0.46%)	31/8542 (0.36%)	37/8576 (0.43%)	9/2954 (0.30%)	11/2972 (0.37%)
Bundle branch block bilateral ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Bundle branch block left ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Bundle branch block right ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Cardiac aneurysm ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Cardiac arrest ^†^A # participants affected / at risk	42/8502 (0.49%)	43/8542 (0.50%)	43/8576 (0.50%)	15/2954 (0.51%)	10/2972 (0.34%)
Cardiac disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Cardiac failure ^†^A # participants affected / at risk	15/8502 (0.18%)	10/8542 (0.12%)	9/8576 (0.10%)	3/2954 (0.10%)	5/2972 (0.17%)
Cardiac failure acute ^†^A # participants affected / at risk	67/8502 (0.79%)	46/8542 (0.54%)	62/8576 (0.72%)	28/2954 (0.95%)	25/2972 (0.84%)
Cardiac failure chronic ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Cardiac failure congestive ^†^A # participants affected / at risk	510/8502 (6.00%)	565/8542 (6.61%)	536/8576 (6.25%)	202/2954 (6.84%)	212/2972 (7.13%)
Cardiac pseudoaneurysm ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Cardiac tamponade ^†^A # participants affected / at risk	0/8502 (0.00%)	4/8542 (0.05%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Cardiac valve disease ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Cardiac valve sclerosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Cardio-respiratory arrest ^†^A # participants affected / at risk	10/8502 (0.12%)	7/8542 (0.08%)	7/8576 (0.08%)	2/2954 (0.07%)	3/2972 (0.10%)
Cardiogenic shock ^†^A # participants affected / at risk	10/8502 (0.12%)	8/8542 (0.09%)	11/8576 (0.13%)	2/2954 (0.07%)	0/2972 (0.00%)
Cardiomegaly ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Cardiomyopathy ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Cardiopulmonary failure ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	4/8576 (0.05%)	0/2954 (0.00%)	0/2972 (0.00%)
Cardiovascular disorder ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Conduction disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Congestive cardiomyopathy ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Cor pulmonale ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Coronary artery dilatation ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Coronary artery disease ^†^A # participants affected / at risk	14/8502 (0.16%)	18/8542 (0.21%)	12/8576 (0.14%)	6/2954 (0.20%)	2/2972 (0.07%)
Coronary artery occlusion ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Diabetic cardiomyopathy ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Dressler's syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Electromechanical dissociation ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Extrasystoles ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Heart valve incompetence ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	2/2954 (0.07%)	0/2972 (0.00%)
Hypertensive heart disease ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Intracardiac thrombus ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Ischaemic cardiomyopathy ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	4/8576 (0.05%)	0/2954 (0.00%)	0/2972 (0.00%)
Left ventricular dysfunction ^†^A # participants affected / at risk	2/8502 (0.02%)	5/8542 (0.06%)	1/8576 (0.01%)	0/2954 (0.00%)	2/2972 (0.07%)
Left ventricular failure ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	3/2972 (0.10%)
Low cardiac output syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Mitral valve disease ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Mitral valve incompetence ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	2/8576 (0.02%)	0/2954 (0.00%)	2/2972 (0.07%)
Mitral valve stenosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Myocardial infarction ^†^A # participants affected / at risk	551/8502 (6.48%)	538/8542 (6.30%)	524/8576 (6.11%)	155/2954 (5.25%)	190/2972 (6.39%)
Myocardial ischaemia ^†^A # participants affected / at risk	13/8502 (0.15%)	10/8542 (0.12%)	13/8576 (0.15%)	4/2954 (0.14%)	4/2972 (0.13%)
Myocarditis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Nodal arrhythmia ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Nodal rhythm ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pacemaker generated arrhythmia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Palpitations ^†^A # participants affected / at risk	9/8502 (0.11%)	13/8542 (0.15%)	7/8576 (0.08%)	2/2954 (0.07%)	1/2972 (0.03%)
Pericardial disease ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Pericardial effusion ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	3/8576 (0.03%)	1/2954 (0.03%)	1/2972 (0.03%)
Pericardial haemorrhage ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Pericarditis ^†^A # participants affected / at risk	0/8502 (0.00%)	5/8542 (0.06%)	5/8576 (0.06%)	3/2954 (0.10%)	1/2972 (0.03%)
Prinzmetal angina ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Right ventricular failure ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Sick sinus syndrome ^†^A # participants affected / at risk	11/8502 (0.13%)	9/8542 (0.11%)	13/8576 (0.15%)	5/2954 (0.17%)	2/2972 (0.07%)
Sinoatrial block ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Sinus arrest ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Sinus arrhythmia ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Sinus bradycardia ^†^A # participants affected / at risk	6/8502 (0.07%)	8/8542 (0.09%)	5/8576 (0.06%)	5/2954 (0.17%)	0/2972 (0.00%)
Sinus tachycardia ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Supraventricular extrasystoles ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Supraventricular tachycardia ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Tachyarrhythmia ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Tachycardia ^†^A # participants affected / at risk	7/8502 (0.08%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	0/2972 (0.00%)
Trifascicular block ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Ventricular arrhythmia ^†^A # participants affected / at risk	72/8502 (0.85%)	93/8542 (1.09%)	75/8576 (0.87%)	20/2954 (0.68%)	27/2972 (0.91%)
Ventricular dysfunction ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Ventricular extrasystoles ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Ventricular fibrillation ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Ventricular remodeling ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Ventricular tachyarrhythmia ^†^A # participants affected / at risk	26/8502 (0.31%)	21/8542 (0.25%)	17/8576 (0.20%)	8/2954 (0.27%)	3/2972 (0.10%)
Ventricular tachycardia ^†^A # participants affected / at risk	7/8502 (0.08%)	8/8542 (0.09%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Wandering pacemaker ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Wolff-Parkinson-White syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Congenital, familial and genetic disorders
Alagille syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Arteriovenous malformation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Atrial septal defect ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Congenital cystic kidney disease ^†^A # participants affected / at risk	3/8502 (0.04%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Congenital teratoma ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Dolichocolon ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Fallot's tetralogy ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Fragile X syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal angiodysplasia ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal angiodysplasia haemorrhagic ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal arteriovenous malformation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal malformation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Horseshoe kidney ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hydrocele ^†^A # participants affected / at risk	3/8502 (0.04%)	5/8542 (0.06%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Kidney malformation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Limb reduction defect ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Meningomyelocele ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Neural tube defect ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Oculopharyngeal dystrophy ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Osteogenesis imperfecta ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Phimosis ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Preternatural anus ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pyloric stenosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Sickle cell anaemia ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Spondylolisthesis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	0/2972 (0.00%)
Transposition of the great vessels ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Turner's syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Ventricular septal defect ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Ear and labyrinth disorders
Acute vestibular syndrome ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	2/2954 (0.07%)	0/2972 (0.00%)
Cerumen impaction ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Deafness ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Deafness neurosensory ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Ear disorder ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Ear pain ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hearing impaired ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Meniere's disease ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Middle ear disorder ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Middle ear inflammation ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Otorrhoea ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Sudden hearing loss ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Tinnitus ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Vertigo ^†^A # participants affected / at risk	32/8502 (0.38%)	22/8542 (0.26%)	32/8576 (0.37%)	13/2954 (0.44%)	19/2972 (0.64%)
Vertigo labyrinthine ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Vertigo positional ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	1/8576 (0.01%)	2/2954 (0.07%)	1/2972 (0.03%)
Vestibular ataxia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Vestibular disorder ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Vestibular neuronitis ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Endocrine disorders
Addison's disease ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Adrenal insufficiency ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Adrenal mass ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Adrenocortical insufficiency acute ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Antidiuretic hormone abnormality ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Endocrine disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Goitre ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	4/8576 (0.05%)	1/2954 (0.03%)	0/2972 (0.00%)
Hyperthyroidism ^†^A # participants affected / at risk	6/8502 (0.07%)	5/8542 (0.06%)	9/8576 (0.10%)	2/2954 (0.07%)	1/2972 (0.03%)
Hypopituitarism ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hypothyroidism ^†^A # participants affected / at risk	4/8502 (0.05%)	7/8542 (0.08%)	5/8576 (0.06%)	2/2954 (0.07%)	0/2972 (0.00%)
Secondary adrenocortical insufficiency ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Thyroid cyst ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Thyroid mass ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Thyroiditis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Eye disorders
Amaurosis fugax ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Blindness ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Cataract ^†^A # participants affected / at risk	14/8502 (0.16%)	11/8542 (0.13%)	16/8576 (0.19%)	4/2954 (0.14%)	1/2972 (0.03%)
Cataract diabetic ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Choroidal detachment ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Choroidal haemorrhage ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Conjunctivitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Corneal infiltrates ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Diabetic retinal oedema ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Diabetic retinopathy ^†^A # participants affected / at risk	5/8502 (0.06%)	3/8542 (0.04%)	5/8576 (0.06%)	2/2954 (0.07%)	3/2972 (0.10%)
Diplopia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Endocrine ophthalmopathy ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Endophthalmitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Extraocular muscle paresis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	2/2972 (0.07%)
Eye degenerative disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Eye disorder ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Eye haemorrhage ^†^A # participants affected / at risk	4/8502 (0.05%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Eyelid ptosis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Glaucoma ^†^A # participants affected / at risk	4/8502 (0.05%)	13/8542 (0.15%)	6/8576 (0.07%)	3/2954 (0.10%)	2/2972 (0.07%)
Lacrimation increased ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Macular degeneration ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Macular oedema ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Maculopathy ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Miosis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Open angle glaucoma ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Optic ischaemic neuropathy ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Optic neuropathy ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Pseudophakia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Pterygium ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal artery embolism ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal artery occlusion ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal artery thrombosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal degeneration ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal detachment ^†^A # participants affected / at risk	8/8502 (0.09%)	8/8542 (0.09%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Retinal disorder ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal infarction ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal ischaemia ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal neovascularisation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal vascular disorder ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal vascular thrombosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal vein occlusion ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinal vein thrombosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Retinopathy ^†^A # participants affected / at risk	4/8502 (0.05%)	6/8542 (0.07%)	4/8576 (0.05%)	1/2954 (0.03%)	0/2972 (0.00%)
Retinopathy hypertensive ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Retinopathy proliferative ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Swollen tear duct ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Ulcerative keratitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Vision blurred ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Visual acuity reduced ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Visual disturbance ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Vitreous detachment ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Vitreous haemorrhage ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Vitreous opacities ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal disorders
Abdominal adhesions ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Abdominal discomfort ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Abdominal distension ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Abdominal hernia ^†^A # participants affected / at risk	3/8502 (0.04%)	4/8542 (0.05%)	7/8576 (0.08%)	1/2954 (0.03%)	2/2972 (0.07%)
Abdominal mass ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Abdominal pain ^†^A # participants affected / at risk	54/8502 (0.64%)	29/8542 (0.34%)	47/8576 (0.55%)	4/2954 (0.14%)	14/2972 (0.47%)
Abdominal pain lower ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	1/8576 (0.01%)	1/2954 (0.03%)	1/2972 (0.03%)
Abdominal pain upper ^†^A # participants affected / at risk	20/8502 (0.24%)	25/8542 (0.29%)	19/8576 (0.22%)	8/2954 (0.27%)	3/2972 (0.10%)
Acute abdomen ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Alcoholic pancreatitis ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Anal dilatation ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Anal fissure ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Anal fistula ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Anal haemorrhage ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Anal polyp ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Anal ulcer ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Aphthous stomatitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Appendicitis perforated ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Ascites ^†^A # participants affected / at risk	3/8502 (0.04%)	4/8542 (0.05%)	5/8576 (0.06%)	1/2954 (0.03%)	0/2972 (0.00%)
Barrett's oesophagus ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Change of bowel habit ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Cheilitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Chronic gastrointestinal bleeding ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Coeliac disease ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Colitis ^†^A # participants affected / at risk	9/8502 (0.11%)	6/8542 (0.07%)	7/8576 (0.08%)	1/2954 (0.03%)	1/2972 (0.03%)
Colitis ischaemic ^†^A # participants affected / at risk	5/8502 (0.06%)	2/8542 (0.02%)	13/8576 (0.15%)	0/2954 (0.00%)	0/2972 (0.00%)
Colitis ulcerative ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	0/8576 (0.00%)	2/2954 (0.07%)	0/2972 (0.00%)
Colonic obstruction ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Colonic polyp ^†^A # participants affected / at risk	4/8502 (0.05%)	7/8542 (0.08%)	5/8576 (0.06%)	3/2954 (0.10%)	3/2972 (0.10%)
Colonic pseudo-obstruction ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Colonic stenosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Constipation ^†^A # participants affected / at risk	21/8502 (0.25%)	13/8542 (0.15%)	24/8576 (0.28%)	3/2954 (0.10%)	8/2972 (0.27%)
Crohn's disease ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Diabetic gastropathy ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Diarrhoea ^†^A # participants affected / at risk	54/8502 (0.64%)	47/8542 (0.55%)	38/8576 (0.44%)	13/2954 (0.44%)	5/2972 (0.17%)
Diarrhoea haemorrhagic ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	0/2972 (0.00%)
Diverticular perforation ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Diverticulitis intestinal haemorrhagic ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Diverticulum ^†^A # participants affected / at risk	7/8502 (0.08%)	9/8542 (0.11%)	8/8576 (0.09%)	5/2954 (0.17%)	2/2972 (0.07%)
Diverticulum intestinal ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	4/8576 (0.05%)	5/2954 (0.17%)	4/2972 (0.13%)
Diverticulum intestinal haemorrhagic ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Diverticulum oesophageal ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Duodenal fistula ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Duodenal obstruction ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Duodenal perforation ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Duodenal ulcer ^†^A # participants affected / at risk	18/8502 (0.21%)	14/8542 (0.16%)	12/8576 (0.14%)	5/2954 (0.17%)	3/2972 (0.10%)
Duodenal ulcer haemorrhage ^†^A # participants affected / at risk	8/8502 (0.09%)	5/8542 (0.06%)	4/8576 (0.05%)	2/2954 (0.07%)	0/2972 (0.00%)
Duodenal ulcer perforation ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Duodenitis ^†^A # participants affected / at risk	1/8502 (0.01%)	8/8542 (0.09%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Duodenogastric reflux ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Dyspepsia ^†^A # participants affected / at risk	10/8502 (0.12%)	8/8542 (0.09%)	5/8576 (0.06%)	5/2954 (0.17%)	1/2972 (0.03%)
Dysphagia ^†^A # participants affected / at risk	8/8502 (0.09%)	7/8542 (0.08%)	11/8576 (0.13%)	2/2954 (0.07%)	1/2972 (0.03%)
Enteritis ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Enterocele ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Enterocolitis ^†^A # participants affected / at risk	3/8502 (0.04%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Enterocolitis haemorrhagic ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Enterocolonic fistula ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Enterocutaneous fistula ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Enterovesical fistula ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Epigastric discomfort ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	3/8576 (0.03%)	0/2954 (0.00%)	0/2972 (0.00%)
Erosive oesophagitis ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Faecal incontinence ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Faecaloma ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Femoral hernia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Food poisoning ^†^A # participants affected / at risk	4/8502 (0.05%)	3/8542 (0.04%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Gastric antral vascular ectasia ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastric disorder ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	1/2972 (0.03%)
Gastric haemorrhage ^†^A # participants affected / at risk	7/8502 (0.08%)	8/8542 (0.09%)	7/8576 (0.08%)	3/2954 (0.10%)	3/2972 (0.10%)
Gastric hypermotility ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastric perforation ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastric polyps ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	2/8576 (0.02%)	2/2954 (0.07%)	1/2972 (0.03%)
Gastric ulcer ^†^A # participants affected / at risk	24/8502 (0.28%)	28/8542 (0.33%)	25/8576 (0.29%)	7/2954 (0.24%)	7/2972 (0.24%)
Gastric ulcer haemorrhage ^†^A # participants affected / at risk	7/8502 (0.08%)	10/8542 (0.12%)	8/8576 (0.09%)	7/2954 (0.24%)	3/2972 (0.10%)
Gastric ulcer perforation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastritis ^†^A # participants affected / at risk	32/8502 (0.38%)	32/8542 (0.37%)	33/8576 (0.38%)	9/2954 (0.30%)	17/2972 (0.57%)
Gastritis erosive ^†^A # participants affected / at risk	5/8502 (0.06%)	7/8542 (0.08%)	2/8576 (0.02%)	3/2954 (0.10%)	1/2972 (0.03%)
Gastritis haemorrhagic ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Gastroduodenitis ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	0/8576 (0.00%)	2/2954 (0.07%)	1/2972 (0.03%)
Gastrointestinal disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	2/2972 (0.07%)
Gastrointestinal fistula ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal haemorrhage ^†^A # participants affected / at risk	70/8502 (0.82%)	68/8542 (0.80%)	54/8576 (0.63%)	23/2954 (0.78%)	13/2972 (0.44%)
Gastrointestinal inflammation ^†^A # participants affected / at risk	0/8502 (0.00%)	4/8542 (0.05%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal ischaemia ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal mucosal disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal necrosis ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal obstruction ^†^A # participants affected / at risk	4/8502 (0.05%)	4/8542 (0.05%)	5/8576 (0.06%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal oedema ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal pain ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Gastrointestinal perforation ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal stenosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastrointestinal ulcer ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Gastrointestinal ulcer haemorrhage ^†^A # participants affected / at risk	2/8502 (0.02%)	4/8542 (0.05%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Gastrooesophageal reflux disease ^†^A # participants affected / at risk	19/8502 (0.22%)	10/8542 (0.12%)	11/8576 (0.13%)	5/2954 (0.17%)	2/2972 (0.07%)
Gastroptosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Gingivitis ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Haematemesis ^†^A # participants affected / at risk	11/8502 (0.13%)	9/8542 (0.11%)	10/8576 (0.12%)	2/2954 (0.07%)	3/2972 (0.10%)
Haematochezia ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Haemorrhoidal haemorrhage ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	2/2972 (0.07%)
Haemorrhoids ^†^A # participants affected / at risk	7/8502 (0.08%)	10/8542 (0.12%)	6/8576 (0.07%)	8/2954 (0.27%)	6/2972 (0.20%)
Hiatus hernia ^†^A # participants affected / at risk	9/8502 (0.11%)	6/8542 (0.07%)	4/8576 (0.05%)	3/2954 (0.10%)	3/2972 (0.10%)
Hiatus hernia, obstructive ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Ileus ^†^A # participants affected / at risk	4/8502 (0.05%)	9/8542 (0.11%)	6/8576 (0.07%)	3/2954 (0.10%)	8/2972 (0.27%)
Ileus paralytic ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Impaired gastric emptying ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Inflammatory bowel disease ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	0/8576 (0.00%)	1/2954 (0.03%)	1/2972 (0.03%)
Inguinal hernia ^†^A # participants affected / at risk	25/8502 (0.29%)	36/8542 (0.42%)	27/8576 (0.31%)	2/2954 (0.07%)	10/2972 (0.34%)
Inguinal hernia, obstructive ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Intestinal angina ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Intestinal functional disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Intestinal haemorrhage ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Intestinal infarction ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	2/8576 (0.02%)	1/2954 (0.03%)	1/2972 (0.03%)
Intestinal ischaemia ^†^A # participants affected / at risk	4/8502 (0.05%)	3/8542 (0.04%)	4/8576 (0.05%)	1/2954 (0.03%)	1/2972 (0.03%)
Intestinal obstruction ^†^A # participants affected / at risk	13/8502 (0.15%)	14/8542 (0.16%)	13/8576 (0.15%)	7/2954 (0.24%)	4/2972 (0.13%)
Intestinal perforation ^†^A # participants affected / at risk	3/8502 (0.04%)	4/8542 (0.05%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Intestinal polyp ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Intra-abdominal haematoma ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	2/8576 (0.02%)	2/2954 (0.07%)	0/2972 (0.00%)
Irritable bowel syndrome ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	2/8576 (0.02%)	1/2954 (0.03%)	1/2972 (0.03%)
Jejunitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Large intestinal haemorrhage ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Large intestinal obstruction ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	1/2972 (0.03%)
Large intestinal ulcer ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Large intestine perforation ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Lip oedema ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Lower gastrointestinal haemorrhage ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Lumbar hernia ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Mallory-Weiss syndrome ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Mechanical ileus ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Melaena ^†^A # participants affected / at risk	11/8502 (0.13%)	6/8542 (0.07%)	13/8576 (0.15%)	2/2954 (0.07%)	2/2972 (0.07%)
Melanosis coli ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Mesenteric artery embolism ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Mesenteric artery stenosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Mesenteric artery thrombosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Mesenteric occlusion ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Mesenteric vein thrombosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Mouth cyst ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Mouth haemorrhage ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Mouth ulceration ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Nausea ^†^A # participants affected / at risk	27/8502 (0.32%)	27/8542 (0.32%)	21/8576 (0.24%)	7/2954 (0.24%)	7/2972 (0.24%)
Necrotising colitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Obstruction gastric ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Odynophagia ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal achalasia ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal dilatation ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal dysplasia ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal haemorrhage ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal obstruction ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal perforation ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal polyp ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal rupture ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal stenosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Oesophageal ulcer ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Oesophageal ulcer haemorrhage ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophageal varices haemorrhage ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophagitis ^†^A # participants affected / at risk	6/8502 (0.07%)	18/8542 (0.21%)	8/8576 (0.09%)	3/2954 (0.10%)	2/2972 (0.07%)
Oesophagitis haemorrhagic ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oesophagitis ulcerative ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oral pain ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pancreatic mass ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	0/8576 (0.00%)	1/2954 (0.03%)	1/2972 (0.03%)
Pancreatic pseudocyst ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pancreatitis ^†^A # participants affected / at risk	22/8502 (0.26%)	21/8542 (0.25%)	17/8576 (0.20%)	6/2954 (0.20%)	3/2972 (0.10%)
Pancreatitis acute ^†^A # participants affected / at risk	9/8502 (0.11%)	13/8542 (0.15%)	8/8576 (0.09%)	4/2954 (0.14%)	5/2972 (0.17%)
Pancreatitis chronic ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	5/8576 (0.06%)	2/2954 (0.07%)	4/2972 (0.13%)
Pancreatitis necrotising ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Pancreatolithiasis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Paraesthesia oral ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Peptic ulcer ^†^A # participants affected / at risk	10/8502 (0.12%)	5/8542 (0.06%)	12/8576 (0.14%)	3/2954 (0.10%)	4/2972 (0.13%)
Peptic ulcer haemorrhage ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Peptic ulcer perforation ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Periproctitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Peritoneal adhesions ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Peritoneal effusion ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Peritoneal haemorrhage ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Peritonitis ^†^A # participants affected / at risk	4/8502 (0.05%)	3/8542 (0.04%)	6/8576 (0.07%)	2/2954 (0.07%)	2/2972 (0.07%)
Pharyngoesophageal diverticulum ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Proctitis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Proctocolitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Rectal haemorrhage ^†^A # participants affected / at risk	21/8502 (0.25%)	14/8542 (0.16%)	12/8576 (0.14%)	5/2954 (0.17%)	8/2972 (0.27%)
Rectal obstruction ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Rectal polyp ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Rectal prolapse ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Reflux gastritis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Reflux oesophagitis ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	3/8576 (0.03%)	1/2954 (0.03%)	4/2972 (0.13%)
Retroperitoneal haematoma ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Retroperitoneal haemorrhage ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Salivary gland calculus ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Salivary gland enlargement ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Salivary hypersecretion ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Small intestinal haemorrhage ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Small intestinal obstruction ^†^A # participants affected / at risk	11/8502 (0.13%)	14/8542 (0.16%)	5/8576 (0.06%)	1/2954 (0.03%)	3/2972 (0.10%)
Small intestinal stenosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Small intestinal ulcer haemorrhage ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Stomatitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Subileus ^†^A # participants affected / at risk	4/8502 (0.05%)	2/8542 (0.02%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Swollen tongue ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Toothache ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Umbilical hernia ^†^A # participants affected / at risk	2/8502 (0.02%)	4/8542 (0.05%)	8/8576 (0.09%)	2/2954 (0.07%)	2/2972 (0.07%)
Upper gastrointestinal haemorrhage ^†^A # participants affected / at risk	18/8502 (0.21%)	23/8542 (0.27%)	20/8576 (0.23%)	8/2954 (0.27%)	7/2972 (0.24%)
Uraemic gastropathy ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Varices oesophageal ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Volvulus ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Vomiting ^†^A # participants affected / at risk	37/8502 (0.44%)	33/8542 (0.39%)	30/8576 (0.35%)	6/2954 (0.20%)	6/2972 (0.20%)
General disorders
Abasia ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Accidental death ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Adverse drug reaction ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Application site bleeding ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Asthenia ^†^A # participants affected / at risk	20/8502 (0.24%)	20/8542 (0.23%)	27/8576 (0.31%)	8/2954 (0.27%)	5/2972 (0.17%)
Cardiac death ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Chest discomfort ^†^A # participants affected / at risk	8/8502 (0.09%)	7/8542 (0.08%)	12/8576 (0.14%)	3/2954 (0.10%)	3/2972 (0.10%)
Chest pain ^†^A # participants affected / at risk	146/8502 (1.72%)	120/8542 (1.40%)	127/8576 (1.48%)	43/2954 (1.46%)	28/2972 (0.94%)
Chills ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Chronic fatigue syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Death ^†^A # participants affected / at risk	37/8502 (0.44%)	52/8542 (0.61%)	53/8576 (0.62%)	13/2954 (0.44%)	12/2972 (0.40%)
Discomfort ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Drowning ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	1/2972 (0.03%)
Drug interaction ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Drug intolerance ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Electrocution ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Exercise tolerance decreased ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Face oedema ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Fatigue ^†^A # participants affected / at risk	10/8502 (0.12%)	4/8542 (0.05%)	8/8576 (0.09%)	1/2954 (0.03%)	1/2972 (0.03%)
Gait deviation ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gait disturbance ^†^A # participants affected / at risk	6/8502 (0.07%)	3/8542 (0.04%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
General physical health deterioration ^†^A # participants affected / at risk	10/8502 (0.12%)	10/8542 (0.12%)	2/8576 (0.02%)	4/2954 (0.14%)	1/2972 (0.03%)
Generalised oedema ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Granuloma ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	2/2972 (0.07%)
Hernia ^†^A # participants affected / at risk	4/8502 (0.05%)	11/8542 (0.13%)	7/8576 (0.08%)	0/2954 (0.00%)	2/2972 (0.07%)
Hernia obstructive ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Hyperthermia ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Hypothermia ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Impaired healing ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Implant site effusion ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Implant site haematoma ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Inflammation ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Inflammation of wound ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Inflammatory pain ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Irritability ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Ischaemic ulcer ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Loss of control of legs ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Malaise ^†^A # participants affected / at risk	8/8502 (0.09%)	10/8542 (0.12%)	4/8576 (0.05%)	1/2954 (0.03%)	0/2972 (0.00%)
Mass ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Microlithiasis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Mucosal inflammation ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Multi-organ failure ^†^A # participants affected / at risk	12/8502 (0.14%)	11/8542 (0.13%)	16/8576 (0.19%)	3/2954 (0.10%)	7/2972 (0.24%)
Multimorbidity ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Necrosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Non-cardiac chest pain ^†^A # participants affected / at risk	38/8502 (0.45%)	39/8542 (0.46%)	33/8576 (0.38%)	15/2954 (0.51%)	13/2972 (0.44%)
Oedema ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Oedema peripheral ^†^A # participants affected / at risk	5/8502 (0.06%)	11/8542 (0.13%)	9/8576 (0.10%)	0/2954 (0.00%)	0/2972 (0.00%)
Orthostatic intolerance ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Pain ^†^A # participants affected / at risk	4/8502 (0.05%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	2/2972 (0.07%)
Polyp ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pre-existing disease ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pyrexia ^†^A # participants affected / at risk	35/8502 (0.41%)	30/8542 (0.35%)	29/8576 (0.34%)	4/2954 (0.14%)	3/2972 (0.10%)
Secretion discharge ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Submandibular mass ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Sudden cardiac death ^†^A # participants affected / at risk	168/8502 (1.98%)	178/8542 (2.08%)	163/8576 (1.90%)	80/2954 (2.71%)	78/2972 (2.62%)
Sudden death ^†^A # participants affected / at risk	12/8502 (0.14%)	15/8542 (0.18%)	17/8576 (0.20%)	3/2954 (0.10%)	3/2972 (0.10%)
Systemic inflammatory response syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Ulcer ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Ulcer haemorrhage ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatobiliary disorders
Acute hepatic failure ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Alcoholic liver disease ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Autoimmune hepatitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Bile duct obstruction ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Bile duct stenosis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	2/2972 (0.07%)
Bile duct stone ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	7/8576 (0.08%)	1/2954 (0.03%)	3/2972 (0.10%)
Biliary colic ^†^A # participants affected / at risk	4/8502 (0.05%)	3/8542 (0.04%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Biliary dilatation ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Biliary dyskinesia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Biliary ischaemia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Biliary tract disorder ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Cholangitis ^†^A # participants affected / at risk	11/8502 (0.13%)	3/8542 (0.04%)	5/8576 (0.06%)	3/2954 (0.10%)	1/2972 (0.03%)
Cholangitis acute ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Cholecystitis ^†^A # participants affected / at risk	23/8502 (0.27%)	28/8542 (0.33%)	43/8576 (0.50%)	12/2954 (0.41%)	11/2972 (0.37%)
Cholecystitis acute ^†^A # participants affected / at risk	14/8502 (0.16%)	20/8542 (0.23%)	13/8576 (0.15%)	3/2954 (0.10%)	6/2972 (0.20%)
Cholecystitis chronic ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	1/8576 (0.01%)	0/2954 (0.00%)	2/2972 (0.07%)
Cholelithiasis ^†^A # participants affected / at risk	36/8502 (0.42%)	36/8542 (0.42%)	28/8576 (0.33%)	15/2954 (0.51%)	10/2972 (0.34%)
Cholelithiasis obstructive ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Cholestasis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	4/8576 (0.05%)	1/2954 (0.03%)	0/2972 (0.00%)
Chronic hepatitis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Cirrhosis alcoholic ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gallbladder disorder ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Gallbladder necrosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gallbladder perforation ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatic cirrhosis ^†^A # participants affected / at risk	10/8502 (0.12%)	6/8542 (0.07%)	5/8576 (0.06%)	0/2954 (0.00%)	1/2972 (0.03%)
Hepatic cyst ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Hepatic failure ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	2/2954 (0.07%)	1/2972 (0.03%)
Hepatic function abnormal ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatic lesion ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Hepatic necrosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatic pain ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatic vein thrombosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Hepatitis ^†^A # participants affected / at risk	8/8502 (0.09%)	4/8542 (0.05%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Hepatitis acute ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Hepatitis toxic ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatocellular injury ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Hepatomegaly ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatorenal syndrome ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatotoxicity ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hydrocholecystis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hyperbilirubinaemia ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Jaundice ^†^A # participants affected / at risk	3/8502 (0.04%)	5/8542 (0.06%)	5/8576 (0.06%)	2/2954 (0.07%)	1/2972 (0.03%)
Jaundice cholestatic ^†^A # participants affected / at risk	2/8502 (0.02%)	5/8542 (0.06%)	2/8576 (0.02%)	3/2954 (0.10%)	1/2972 (0.03%)
Liver disorder ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	3/2972 (0.10%)
Portal hypertension ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Portal vein phlebitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Portal vein thrombosis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Post cholecystectomy syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Immune system disorders
Allergic oedema ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Allergy to arthropod sting ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Anaphylactic reaction ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Anaphylactic shock ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Anaphylactoid shock ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Drug hypersensitivity ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Food allergy ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hypersensitivity ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	5/8576 (0.06%)	1/2954 (0.03%)	1/2972 (0.03%)
Immunodeficiency ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Immunosuppression ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Insulin autoimmune syndrome ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pancreas transplant rejection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Sarcoidosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Infections and infestations
AIDS related complication ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Abdominal abscess ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	1/8576 (0.01%)	1/2954 (0.03%)	2/2972 (0.07%)
Abdominal infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Abdominal sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	3/8576 (0.03%)	2/2954 (0.07%)	1/2972 (0.03%)
Abscess intestinal ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Abscess limb ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Acquired immunodeficiency syndrome ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Acute sinusitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Adenoviral upper respiratory infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Anal abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Anogenital warts ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Anorectal infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Appendiceal abscess ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Appendicitis ^†^A # participants affected / at risk	14/8502 (0.16%)	9/8542 (0.11%)	12/8576 (0.14%)	4/2954 (0.14%)	4/2972 (0.13%)
Application site infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Arteriosclerotic gangrene ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Arthritis bacterial ^†^A # participants affected / at risk	5/8502 (0.06%)	1/8542 (0.01%)	5/8576 (0.06%)	1/2954 (0.03%)	0/2972 (0.00%)
Arthritis infective ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Aspergilloma ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Bacteraemia ^†^A # participants affected / at risk	5/8502 (0.06%)	3/8542 (0.04%)	3/8576 (0.03%)	2/2954 (0.07%)	0/2972 (0.00%)
Bacterial food poisoning ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Bacterial infection ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Bacterial sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Bacteriuria ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Biliary sepsis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Biliary tract infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Bone tuberculosis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Boutonneuse fever ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Breast abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Bronchiectasis ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	2/8576 (0.02%)	2/2954 (0.07%)	1/2972 (0.03%)
Bronchitis ^†^A # participants affected / at risk	41/8502 (0.48%)	33/8542 (0.39%)	44/8576 (0.51%)	20/2954 (0.68%)	16/2972 (0.54%)
Bronchitis viral ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Bronchopneumonia ^†^A # participants affected / at risk	29/8502 (0.34%)	32/8542 (0.37%)	23/8576 (0.27%)	9/2954 (0.30%)	10/2972 (0.34%)
Bursitis infective ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Campylobacter intestinal infection ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Candida sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Candidiasis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Carbuncle ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Catheter related infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Catheter sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Cavernous sinus thrombosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Cellulitis ^†^A # participants affected / at risk	30/8502 (0.35%)	34/8542 (0.40%)	51/8576 (0.59%)	15/2954 (0.51%)	17/2972 (0.57%)
Cellulitis of male external genital organ ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Cellulitis orbital ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Central nervous system infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Cholecystitis infective ^†^A # participants affected / at risk	4/8502 (0.05%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Chronic sinusitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Citrobacter infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Clostridial infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Clostridium colitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Clostridium difficile colitis ^†^A # participants affected / at risk	5/8502 (0.06%)	1/8542 (0.01%)	4/8576 (0.05%)	1/2954 (0.03%)	3/2972 (0.10%)
Clostridium difficile sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Creutzfeldt-Jakob disease ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Cystitis ^†^A # participants affected / at risk	6/8502 (0.07%)	8/8542 (0.09%)	12/8576 (0.14%)	6/2954 (0.20%)	6/2972 (0.20%)
Dengue fever ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	1/2972 (0.03%)
Device related infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Diarrhoea infectious ^†^A # participants affected / at risk	2/8502 (0.02%)	4/8542 (0.05%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Diverticulitis ^†^A # participants affected / at risk	24/8502 (0.28%)	21/8542 (0.25%)	27/8576 (0.31%)	6/2954 (0.20%)	7/2972 (0.24%)
Ear infection ^†^A # participants affected / at risk	5/8502 (0.06%)	4/8542 (0.05%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Empyema ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	5/8576 (0.06%)	1/2954 (0.03%)	0/2972 (0.00%)
Encephalitis viral ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Endocarditis ^†^A # participants affected / at risk	4/8502 (0.05%)	0/8542 (0.00%)	2/8576 (0.02%)	2/2954 (0.07%)	2/2972 (0.07%)
Endocarditis bacterial ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Enteritis infectious ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Enterobacter pneumonia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Enterococcal bacteraemia ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Enterococcal infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Enterococcal sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Enterocolitis infectious ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Epiglottitis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Erysipelas ^†^A # participants affected / at risk	10/8502 (0.12%)	14/8542 (0.16%)	13/8576 (0.15%)	3/2954 (0.10%)	3/2972 (0.10%)
Escherichia bacteraemia ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Escherichia sepsis ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Escherichia urinary tract infection ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
External ear cellulitis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Extradural abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Eye infection ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Febrile infection ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Fungal infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Furuncle ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gallbladder abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gallbladder empyema ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Gangrene ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Gastric infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastritis viral ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastroenteritis ^†^A # participants affected / at risk	53/8502 (0.62%)	36/8542 (0.42%)	35/8576 (0.41%)	9/2954 (0.30%)	11/2972 (0.37%)
Gastroenteritis salmonella ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastroenteritis staphylococcal ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Gastroenteritis viral ^†^A # participants affected / at risk	5/8502 (0.06%)	2/8542 (0.02%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Gastrointestinal infection ^†^A # participants affected / at risk	2/8502 (0.02%)	4/8542 (0.05%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Genital infection female ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Genitourinary tract infection ^†^A # participants affected / at risk	4/8502 (0.05%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Giardiasis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Graft infection ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Groin abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Groin infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
HIV infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Haematoma infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Helicobacter gastritis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Helicobacter infection ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatic infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatitis A ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatitis B ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Hepatitis C ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	1/2954 (0.03%)	1/2972 (0.03%)
Herpes simplex ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Herpes virus infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Herpes zoster ^†^A # participants affected / at risk	6/8502 (0.07%)	8/8542 (0.09%)	10/8576 (0.12%)	6/2954 (0.20%)	0/2972 (0.00%)
Herpes zoster disseminated ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Herpes zoster infection neurological ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Herpes zoster oticus ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Histoplasmosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Implant site infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Incision site abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Incision site infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Incisional hernia gangrenous ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Infected cyst ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Infected lymphocele ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Infected sebaceous cyst ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Infected skin ulcer ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Infection ^†^A # participants affected / at risk	10/8502 (0.12%)	21/8542 (0.25%)	26/8576 (0.30%)	2/2954 (0.07%)	3/2972 (0.10%)
Infectious mononucleosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Infective exacerbation of chronic obstructive airways disease ^†^A # participants affected / at risk	2/8502 (0.02%)	3/8542 (0.04%)	4/8576 (0.05%)	0/2954 (0.00%)	1/2972 (0.03%)
Influenza ^†^A # participants affected / at risk	4/8502 (0.05%)	5/8542 (0.06%)	4/8576 (0.05%)	0/2954 (0.00%)	3/2972 (0.10%)
Injection site abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Injection site cellulitis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Injection site infection ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Intervertebral discitis ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	0/8576 (0.00%)	1/2954 (0.03%)	1/2972 (0.03%)
Intestinal fistula infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Intestinal gangrene ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Kidney infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Klebsiella infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Klebsiella sepsis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Labyrinthitis ^†^A # participants affected / at risk	2/8502 (0.02%)	4/8542 (0.05%)	2/8576 (0.02%)	4/2954 (0.14%)	1/2972 (0.03%)
Laryngitis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	3/8576 (0.03%)	1/2954 (0.03%)	0/2972 (0.00%)
Leptospirosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Listeriosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Liver abscess ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	4/8576 (0.05%)	0/2954 (0.00%)	0/2972 (0.00%)
Lobar pneumonia ^†^A # participants affected / at risk	16/8502 (0.19%)	15/8542 (0.18%)	19/8576 (0.22%)	3/2954 (0.10%)	7/2972 (0.24%)
Localised infection ^†^A # participants affected / at risk	5/8502 (0.06%)	5/8542 (0.06%)	9/8576 (0.10%)	3/2954 (0.10%)	3/2972 (0.10%)
Lower respiratory tract infection ^†^A # participants affected / at risk	28/8502 (0.33%)	29/8542 (0.34%)	25/8576 (0.29%)	14/2954 (0.47%)	9/2972 (0.30%)
Lung abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Lung infection ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	6/8576 (0.07%)	1/2954 (0.03%)	3/2972 (0.10%)
Lung infection pseudomonal ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Lymphangitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Mastitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Mediastinitis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Meningitis ^†^A # participants affected / at risk	3/8502 (0.04%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Meningoencephalitis herpetic ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Mycotic corneal ulcer ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Myringitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Nasopharyngitis ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	6/8576 (0.07%)	2/2954 (0.07%)	0/2972 (0.00%)
Necrotising fasciitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Neurosyphilis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Neutropenic sepsis ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Nocardiosis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Nosocomial infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Oral viral infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Orchitis ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	2/8576 (0.02%)	1/2954 (0.03%)	2/2972 (0.07%)
Osteomyelitis ^†^A # participants affected / at risk	3/8502 (0.04%)	2/8542 (0.02%)	6/8576 (0.07%)	1/2954 (0.03%)	2/2972 (0.07%)
Osteomyelitis acute ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Osteomyelitis chronic ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	4/8576 (0.05%)	0/2954 (0.00%)	0/2972 (0.00%)
Otitis externa ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Otitis media ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Otitis media acute ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Otitis media chronic ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pancreas infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Parainfluenzae virus infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Paronychia ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pelvic abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Perianal abscess ^†^A # participants affected / at risk	6/8502 (0.07%)	5/8542 (0.06%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Peridiverticular abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Perineal abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Perirectal abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Peritoneal abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Peritoneal infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Peritonsillar abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Petrositis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pharyngitis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	2/8576 (0.02%)	1/2954 (0.03%)	0/2972 (0.00%)
Pharyngitis streptococcal ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Pilonidal cyst ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pleural infection ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumococcal sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Pneumocystis jiroveci pneumonia ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumonia ^†^A # participants affected / at risk	347/8502 (4.08%)	364/8542 (4.26%)	341/8576 (3.98%)	121/2954 (4.10%)	117/2972 (3.94%)
Pneumonia haemophilus ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Pneumonia herpes viral ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumonia legionella ^†^A # participants affected / at risk	0/8502 (0.00%)	3/8542 (0.04%)	3/8576 (0.03%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumonia parainfluenzae viral ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumonia primary atypical ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumonia staphylococcal ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumonia streptococcal ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pneumonia viral ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Post procedural cellulitis ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Post procedural infection ^†^A # participants affected / at risk	5/8502 (0.06%)	4/8542 (0.05%)	8/8576 (0.09%)	0/2954 (0.00%)	3/2972 (0.10%)
Postoperative abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Postoperative wound infection ^†^A # participants affected / at risk	5/8502 (0.06%)	7/8542 (0.08%)	12/8576 (0.14%)	2/2954 (0.07%)	2/2972 (0.07%)
Prostate infection ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Prostatic abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pseudomembranous colitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Pseudomonal sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Psoas abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pulmonary mycosis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Pulmonary sepsis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Pulmonary tuberculosis ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	6/8576 (0.07%)	2/2954 (0.07%)	2/2972 (0.07%)
Purulence ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pyelonephritis ^†^A # participants affected / at risk	16/8502 (0.19%)	16/8542 (0.19%)	10/8576 (0.12%)	8/2954 (0.27%)	9/2972 (0.30%)
Pyelonephritis acute ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	2/8576 (0.02%)	3/2954 (0.10%)	2/2972 (0.07%)
Pyelonephritis chronic ^†^A # participants affected / at risk	4/8502 (0.05%)	1/8542 (0.01%)	7/8576 (0.08%)	3/2954 (0.10%)	3/2972 (0.10%)
Pyoderma ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Pyothorax ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	0/2972 (0.00%)
Rectal abscess ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Renal abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Respiratory tract infection ^†^A # participants affected / at risk	20/8502 (0.24%)	16/8542 (0.19%)	19/8576 (0.22%)	15/2954 (0.51%)	7/2972 (0.24%)
Respiratory tract infection viral ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Retroperitoneal abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Rhinitis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Salmonellosis ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	2/8576 (0.02%)	1/2954 (0.03%)	1/2972 (0.03%)
Scrotal abscess ^†^A # participants affected / at risk	2/8502 (0.02%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Scrub typhus ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Sepsis ^†^A # participants affected / at risk	63/8502 (0.74%)	59/8542 (0.69%)	41/8576 (0.48%)	23/2954 (0.78%)	10/2972 (0.34%)
Septic shock ^†^A # participants affected / at risk	8/8502 (0.09%)	18/8542 (0.21%)	22/8576 (0.26%)	9/2954 (0.30%)	3/2972 (0.10%)
Shunt infection ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Sinusitis ^†^A # participants affected / at risk	3/8502 (0.04%)	3/8542 (0.04%)	7/8576 (0.08%)	0/2954 (0.00%)	1/2972 (0.03%)
Skin infection ^†^A # participants affected / at risk	2/8502 (0.02%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Small intestine gangrene ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Staphylococcal bacteraemia ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Staphylococcal infection ^†^A # participants affected / at risk	1/8502 (0.01%)	3/8542 (0.04%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Staphylococcal osteomyelitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Staphylococcal sepsis ^†^A # participants affected / at risk	3/8502 (0.04%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Streptococcal sepsis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Subcutaneous abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	4/8576 (0.05%)	1/2954 (0.03%)	0/2972 (0.00%)
Subdiaphragmatic abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Sweat gland infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Syphilitic endocarditis of heart valve ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Thrombophlebitis septic ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Tick-borne fever ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Tinea pedis ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Tonsillitis ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Tooth abscess ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Toxoplasmosis ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Tracheitis ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	2/2954 (0.07%)	0/2972 (0.00%)
Tracheobronchitis ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	3/8576 (0.03%)	0/2954 (0.00%)	0/2972 (0.00%)
Tuberculosis ^†^A # participants affected / at risk	4/8502 (0.05%)	3/8542 (0.04%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Tuberculous pleurisy ^†^A # participants affected / at risk	0/8502 (0.00%)	2/8542 (0.02%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Upper respiratory tract infection ^†^A # participants affected / at risk	8/8502 (0.09%)	10/8542 (0.12%)	12/8576 (0.14%)	7/2954 (0.24%)	4/2972 (0.13%)
Urethral carbuncle ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Urethritis ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	1/8576 (0.01%)	0/2954 (0.00%)	1/2972 (0.03%)
Urinary tract infection ^†^A # participants affected / at risk	95/8502 (1.12%)	88/8542 (1.03%)	100/8576 (1.17%)	34/2954 (1.15%)	33/2972 (1.11%)
Urinary tract infection bacterial ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Urinary tract infection enterococcal ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Urogenital infection bacterial ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Urosepsis ^†^A # participants affected / at risk	19/8502 (0.22%)	14/8542 (0.16%)	12/8576 (0.14%)	5/2954 (0.17%)	5/2972 (0.17%)
Vaginal abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Vaginal infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	2/8576 (0.02%)	0/2954 (0.00%)	1/2972 (0.03%)
Varicella ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Viral diarrhoea ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Viral infection ^†^A # participants affected / at risk	6/8502 (0.07%)	3/8542 (0.04%)	5/8576 (0.06%)	2/2954 (0.07%)	3/2972 (0.10%)
Viral upper respiratory tract infection ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	2/2954 (0.07%)	1/2972 (0.03%)
Wound abscess ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Wound infection ^†^A # participants affected / at risk	2/8502 (0.02%)	6/8542 (0.07%)	7/8576 (0.08%)	1/2954 (0.03%)	2/2972 (0.07%)
Wound infection staphylococcal ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Injury, poisoning and procedural complications
Abdominal injury ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Accident ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Accident at home ^†^A # participants affected / at risk	0/8502 (0.00%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Accident at work ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	1/2954 (0.03%)	0/2972 (0.00%)
Accidental exposure ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	0/2954 (0.00%)	0/2972 (0.00%)
Accidental needle stick ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	1/8576 (0.01%)	0/2954 (0.00%)	0/2972 (0.00%)
Accidental overdose ^†^A # participants affected / at risk	1/8502 (0.01%)	2/8542 (0.02%)	3/8576 (0.03%)	0/2954 (0.00%)	1/2972 (0.03%)
Acetabulum fracture ^†^A # participants affected / at risk	1/8502 (0.01%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Adrenal haematoma ^†^A # participants affected / at risk	0/8502 (0.00%)	0/8542 (0.00%)	0/8576 (0.00%)	1/2954 (0.03%)	0/2972 (0.00%)
Alcohol poisoning ^†^A # participants affected / at risk	2/8502 (0.02%)	1/8542 (0.01%)	0/8576 (0.00%)	0/2954 (0.00%)	1/2972 (0.03%)
Anaemia postoperative ^†^A # participants affected / at risk