Trial Outcomes & Findings for Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ (NCT NCT00072462)

NCT ID: NCT00072462

Last Updated: 2024-09-19

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2980 participants
• Primary outcome timeframe: Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Anastrozole Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Overall Study STARTED	1471	1509
Overall Study COMPLETED	1449	1489
Overall Study NOT COMPLETED	22	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Anastrozole n=1471 Participants Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1509 Participants tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo	Total n=2980 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1471 Participants	0 Participants n=1509 Participants	0 Participants n=2980 Participants
Age, Categorical Between 18 and 65 years	1139 Participants n=1471 Participants	1171 Participants n=1509 Participants	2310 Participants n=2980 Participants
Age, Categorical >=65 years	332 Participants n=1471 Participants	338 Participants n=1509 Participants	670 Participants n=2980 Participants
Age, Continuous	60.4 years n=1471 Participants	60.3 years n=1509 Participants	60.3 years n=2980 Participants
Sex: Female, Male Female	1471 Participants n=1471 Participants	1509 Participants n=1509 Participants	2980 Participants n=2980 Participants
Sex: Female, Male Male	0 Participants n=1471 Participants	0 Participants n=1509 Participants	0 Participants n=2980 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Sweden	4 participants n=1471 Participants	4 participants n=1509 Participants	8 participants n=2980 Participants
Region of Enrollment United Kingdom	429 participants n=1471 Participants	460 participants n=1509 Participants	889 participants n=2980 Participants
Region of Enrollment Italy	165 participants n=1471 Participants	158 participants n=1509 Participants	323 participants n=2980 Participants
Region of Enrollment Australia	76 participants n=1471 Participants	92 participants n=1509 Participants	168 participants n=2980 Participants
Region of Enrollment Switzerland	19 participants n=1471 Participants	26 participants n=1509 Participants	45 participants n=2980 Participants
Region of Enrollment Belgium	54 participants n=1471 Participants	50 participants n=1509 Participants	104 participants n=2980 Participants
Region of Enrollment Chile	9 participants n=1471 Participants	8 participants n=1509 Participants	17 participants n=2980 Participants
Region of Enrollment Finland	4 participants n=1471 Participants	3 participants n=1509 Participants	7 participants n=2980 Participants
Region of Enrollment Ireland	42 participants n=1471 Participants	36 participants n=1509 Participants	78 participants n=2980 Participants
Region of Enrollment France	211 participants n=1471 Participants	215 participants n=1509 Participants	426 participants n=2980 Participants
Region of Enrollment Germany	386 participants n=1471 Participants	393 participants n=1509 Participants	779 participants n=2980 Participants
Region of Enrollment Hungary	7 participants n=1471 Participants	8 participants n=1509 Participants	15 participants n=2980 Participants
Region of Enrollment Malta	2 participants n=1471 Participants	2 participants n=1509 Participants	4 participants n=2980 Participants
Region of Enrollment New Zealand	4 participants n=1471 Participants	6 participants n=1509 Participants	10 participants n=2980 Participants
Region of Enrollment Turkey	7 participants n=1471 Participants	8 participants n=1509 Participants	15 participants n=2980 Participants
Region of Enrollment Austria	51 participants n=1471 Participants	39 participants n=1509 Participants	90 participants n=2980 Participants
Region of Enrollment India	1 participants n=1471 Participants	1 participants n=1509 Participants	2 participants n=2980 Participants

PRIMARY outcome

Timeframe: Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Outcome measures

Measure	Anastrozole n=1449 Participants Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1489 Participants tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours	103 Participants	120 Participants

SECONDARY outcome

Timeframe: Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Outcome measures

Measure	Anastrozole n=1449 Participants Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1489 Participants tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours	58 Participants	82 Participants

SECONDARY outcome

Timeframe: Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Outcome measures

Measure	Anastrozole n=1449 Participants Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1489 Participants tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Number of Participants With ER- Breast Cancer Recurrence	24 Participants	15 Participants

SECONDARY outcome

Timeframe: Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Outcome measures

Measure	Anastrozole n=1449 Participants Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1489 Participants tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Number of Breast Cancer Deaths	3 Participants	3 Participants

SECONDARY outcome

Timeframe: Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Outcome measures

Measure	Anastrozole n=1449 Participants Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1489 Participants tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Number of Non-breast Cancer Deaths	59 Participants	65 Participants

Adverse Events

Anastrozole

Serious events: 333 serious events

Other events: 1323 other events

Deaths: 62 deaths

Tamoxifen

Serious events: 371 serious events

Other events: 1380 other events

Deaths: 69 deaths

Serious adverse events

Measure	Anastrozole n=1449 participants at risk Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1489 participants at risk tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Injury, poisoning and procedural complications Alcohol poisoning	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Radiation fibrosis - lung	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Radiation necrosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Radiation pneumonitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fall	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Head injury	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Ligament injury	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Ligament rupture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Multiple injuries	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Road traffic accident	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Tendon rupture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Traumatic anuria	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Aortic dissection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Arterial stenosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Arteriosclerosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Infarction	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Venous insufficiency	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Hypotension	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Arterial thrombosis limb	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Deep vein thrombosis	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.94% 14/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Pelvic venous thrombosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Thrombophlebitis superficial	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Thrombosis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Venous thrombosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Venous thrombosis limb	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Hot flush	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Haematoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Hypertension	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Phlebitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Varicose ulceration	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Varicose vein	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Bunion operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hip arthroplasty	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Joint arthroplasty	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Knee arthroplasty	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Rotator cuff repair	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Mammoplasty	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Aortic valve replacement	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Mitral valve replacement	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Thyroid operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Thyroidectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Eye operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Abdominal hernia repair	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Appendicectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Colectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hernia repair	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Laparotomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Rectal prolapse repair	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cholecystectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Meningioma surgery	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Spinal laminectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Spinal operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hysterectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Oophorectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Oophorectomy bilateral	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Salpingo-oophorectomy bilateral	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine dilation and curettage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine tumour excision	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Nephrectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Removal of inert matter from skin or subcutaneous tissue	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Scar excision	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Skin graft	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cancer surgery	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Debridement	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Elective surgery	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Lesion excision	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Malignant tumour excision	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Wound closure	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Coronary artery bypass	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraductal papilloma of breast	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast angiosarcoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Paget's disease of the breast	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of thyroid gland	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoid tumour of the caecum	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland adenoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrooesophageal cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant palate neoplasm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant peritoneal neoplasm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oral cavity cancer metastatic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectosigmoid cancer recurrent	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haematological malignancy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myeloproliferative disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Focal nodular hyperplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hairy cell leukaemia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleural mesothelioma malignant	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to spine	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic squamous cell carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningeal neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intraocular melanoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeloma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign ovarian tumour	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma recurrent	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer metastatic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fallopian tube cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer recurrent	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiomyolipoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leiomyoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Inflammatory myofibroblastic tumour	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma uterus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Allergy to arthropod bite	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Hypersensitivity	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Pyrexia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Cardiac death	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Death	0.97% 14/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Asthenia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Chest discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Chest pain	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Disease progression	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Fatigue	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Hernia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Malaise	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Multi-organ failure	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Swelling	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Pelvic mass	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Sudden cardiac death	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Anxiety	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Panic attack	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Panic disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Confusional state	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Depression	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Hallucination	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Drug abuse	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Sleep disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Completed suicide	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Suicide attempt	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast haematoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast necrosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Cervical cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Cervical dysplasia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Cervical polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Postmenopausal haemorrhage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Metrorrhagia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Ovarian atrophy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Ovarian cyst	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Cystocele	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometrial disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometrial dysplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometrial hyperplasia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometrial hypertrophy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Rectocele	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine atrophy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine polyp	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.0% 15/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine prolapse	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterovaginal prolapse	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal prolapse	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal haemorrhage	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vulvovaginal discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Acetabulum fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Ankle fracture	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Cartilage injury	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Femoral neck fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Femur fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fibula fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Foot fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Forearm fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Hand fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Hip fracture	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Humerus fracture	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Joint dislocation	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Joint sprain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Limb injury	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Lower limb fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Meniscus lesion	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Patella fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Pelvic fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Radius fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Rib fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Spinal fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Sternal fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Upper limb fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Wrist fracture	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Intentional overdose	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Multiple drug overdose	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Dislocation of joint prosthesis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Post procedural pulmonary embolism	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Seroma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Wound decomposition	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ejection fraction decreased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Heart rate increased	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Haemoglobin decreased	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Alanine aminotransferase increased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Hepatic enzyme increased	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Investigation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Blood glucose fluctuation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Blood glucose increased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Arthroscopy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Intraocular pressure increased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Body temperature increased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Weight decreased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Cystoscopy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Hysteroscopy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Smear cervix abnormal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Atrial fibrillation	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Atrial flutter	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Bradycardia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Bundle branch block left	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Bundle branch block right	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiac arrest	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Extrasystoles	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Supraventricular tachycardia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Tachycardia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Ventricular tachycardia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Palpitations	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Aortic valve incompetence	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Acute coronary syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Acute myocardial infarction	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Angina pectoris	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Angina unstable	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Coronary artery disease	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Coronary artery occlusion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Coronary artery stenosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Myocardial infarction	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiac failure	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiac failure congestive	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Left ventricular failure	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Asthma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Cough	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Laryngeal haemorrhage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Nasal septum deviation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Anaemia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Iron deficiency anaemia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Lymphadenopathy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Arachnoiditis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Encephalitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Brain stem stroke	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Carotid artery occlusion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Carotid artery stenosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cerebral haemorrhage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cerebral infarction	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cerebral ischaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cerebrovascular accident	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Ischaemic stroke	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Transient ischaemic attack	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Trigeminal neuralgia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Multiple sclerosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Headache	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Migraine	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Amnesia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dementia Alzheimer's type	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Hemiparesis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Paresis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Parkinson's disease	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Tremor	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Altered state of consciousness	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Diabetic hyperosmolar coma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dizziness	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Lethargy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Loss of consciousness	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Paraesthesia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Presyncope	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Syncope	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Autonomic nervous system imbalance	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Motor neurone disease	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Carpal tunnel syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Diabetic neuropathy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Guillain-Barre syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Nerve compression	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cervicobrachial syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Sciatica	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Cataract	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Cataract cortical	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Glaucoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Ocular hypertension	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Open angle glaucoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Optic ischaemic neuropathy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Eye irritation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Keratitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Macular hole	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Papilloedema	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal detachment	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal tear	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal vein occlusion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Blindness unilateral	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Vision blurred	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Deafness unilateral	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Tinnitus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Vertigo	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal hernia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Enterocele	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Hiatus hernia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colonic polyp	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gingival hypoplasia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Diverticulum intestinal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Pancreatic disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Pancreatitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Pancreatitis acute	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Anal fistula	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastric haemorrhage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Haematemesis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colitis ischaemic	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colitis ulcerative	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Crohn's disease	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Duodenitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastrooesophagitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Ileitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Oesophagitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Constipation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Diarrhoea	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Frequent bowel movements	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal discomfort	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal pain	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Dyspepsia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Dysphagia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Nausea	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Vomiting	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Intestinal obstruction	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Volvulus of small bowel	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastric ulcer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Intestinal ulcer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Peptic ulcer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Haemorrhoids	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Splenic artery aneurysm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Varices oesophageal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Peritonitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Acute kidney injury	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Hydronephrosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Kidney enlargement	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal artery thrombosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal failure	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal failure acute	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal impairment	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Urethral disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Haematuria	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Incontinence	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Mixed incontinence	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal colic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Stress urinary incontinence	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Urinary incontinence	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Urinary retention	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Nephrolithiasis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Biliary colic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholecystitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholecystitis acute	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholelithiasis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Gallbladder polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cirrhosis alcoholic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Hepatic cirrhosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Hepatic cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Urticaria	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Pruritus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Rash	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Bone pain	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteopenia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteoporosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Fracture nonunion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthralgia	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthritis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteoarthritis	1.0% 15/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Trismus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Foot deformity	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Lumbar spine flattening	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Back disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Back pain	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Neck pain	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Pain in extremity	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Chondropathy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Autoimmune thyroiditis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Goitre	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Hyperthyroidism	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Thyroiditis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Decreased appetite	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Diabetic foot	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Dehydration	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hyponatraemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Diabetes mellitus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Folate deficiency	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Arthritis bacterial	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Breast cellulitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Cellulitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Escherichia infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Escherichia sepsis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pneumococcal sepsis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pneumonia pneumococcal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Streptococcal sepsis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pneumocystis jiroveci pneumonia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Vulvovaginal candidiasis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Abdominal infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Appendicitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Arthritis infective	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Breast abscess	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Bronchiectasis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Bronchitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Bronchopneumonia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Diverticulitis	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Endocarditis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Gastroenteritis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Kidney infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Localised infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Mastitis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Meningitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Nail infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pneumonia	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Postoperative wound infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pyelonephritis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Respiratory tract infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Sepsis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Sialoadenitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Urinary tract infection	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Urosepsis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Wound infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Herpes ophthalmic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Herpes zoster	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Vestibular neuronitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Viral infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Other adverse events

Measure	Anastrozole n=1449 participants at risk Anastrozole: Anastrozole 1mg + Tamoxifen placebo	Tamoxifen n=1489 participants at risk tamoxifen citrate: Tamoxifen 20mg + Anastrozole placebo
Injury, poisoning and procedural complications Ankle fracture	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Bone fragmentation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Bursa injury	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Cartilage injury	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Cervical vertebral fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Femoral neck fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Femur fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Foot fracture	0.97% 14/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 17/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Forearm fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fracture	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fracture displacement	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fractured coccyx	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fractured sacrum	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Haemarthrosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Hand fracture	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Hip fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Humerus fracture	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Joint dislocation	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Lower limb fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Meniscus injury	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Meniscus lesion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Multiple fractures	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Patella fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Radius fracture	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Rib fracture	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Skull fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Spinal fracture	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Traumatic fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Ulna fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Upper limb fracture	1.2% 18/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Wrist fracture	2.1% 30/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.0% 15/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Food poisoning	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Animal bite	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Corneal abrasion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Excoriation	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Fall	1.3% 19/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 16/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Injury	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Ligament injury	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Ligament rupture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Mouth injury	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Muscle rupture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Perineal laceration	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Retinal detachment	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Road traffic accident	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Soft tissue injury	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.87% 13/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Superficial injury of eye	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Tendon rupture	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Tooth injury	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Vascular injury	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Vena cava injury	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Vitreous detachment	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Deep vein thrombosis postoperative	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Device intolerance	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Implant tissue necrosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Postoperative thrombosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Procedural pain	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Seroma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Injury, poisoning and procedural complications Vascular graft occlusion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy lymph gland	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Angiogram	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Arteriogram coronary	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Blood pressure	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Blood pressure abnormal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Blood pressure increased	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Cardiac murmur	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Cardiovascular evaluation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Catheterisation cardiac	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Echocardiogram	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Electrocardiogram	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Electrocardiogram abnormal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Electrocardiogram ST segment depression	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Heart rate decreased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Heart rate irregular	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Scan myocardial perfusion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound Doppler	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Venogram	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Gene mutation identification test positive	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy thyroid gland	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Thyroid function test abnormal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Barium enema	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Barium swallow	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy colon abnormal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy oesophagus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Colonoscopy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Endoscopy upper gastrointestinal tract	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Oesophagogastroscopy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Sigmoidoscopy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound abdomen	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations White blood cell count decreased	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Red blood cell count	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy liver	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Gamma-glutamyltransferase increased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Hepatic enzyme increased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Liver function test abnormal	1.2% 17/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.4% 21/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound biliary tract	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Computerised tomogram	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Endoscopy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Imaging procedure	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Investigation	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Needle biopsy site unspecified normal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Nuclear magnetic resonance imaging	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations X-ray	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Free fatty acids increased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Glucose tolerance test	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Arthroscopy	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Bone densitometry	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Bone density decreased	3.9% 56/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.8% 42/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Acoustic stimulation tests	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Brain scan normal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Scan brain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Body height decreased	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Body temperature increased	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Gastrointestinal examination	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Gynaecological examination	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Neurological examination	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ophthalmological examination	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Orthopedic examination	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Weight decreased	1.6% 23/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.0% 15/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Weight increased	8.7% 126/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	8.9% 133/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Cystoscopy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound kidney	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Aspiration breast	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy breast	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy breast normal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy cervix	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy endometrium	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy endometrium normal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy testes normal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy uterus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Biopsy vagina	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Hysteroscopy	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 16/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Mammogram	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Mammogram abnormal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Mammogram normal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Smear cervix	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Smear cervix abnormal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound breast	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound pelvis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound scan vagina	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Ultrasound uterus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Chest X-ray	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Computerised tomogram thorax	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Laryngoscopy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Sclerotherapy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Investigations Serum ferritin increased	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Arrhythmia	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Atrial fibrillation	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Atrial flutter	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Atrial tachycardia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Bradyarrhythmia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Tachycardia	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiac discomfort	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiac disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiovascular disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Dizziness	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Dyspnoea	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Palpitations	1.3% 19/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Aortic valve incompetence	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Aortic valve stenosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Mitral valve incompetence	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Mitral valve prolapse	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Angina pectoris	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Angina unstable	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Chest pain	0.97% 14/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.0% 15/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Coronary artery disease	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Coronary artery stenosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Myocardial infarction	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Myocardial ischaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Endocarditis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiac failure	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiac failure chronic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Left ventricular failure	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiomegaly	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Cardiomyopathy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Ventricular dysfunction	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Dressler's syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Cardiac disorders Pericardial effusion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Gastrointestinal angiodysplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Heart disease congenital	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Cataract congenital	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Haemangioma of retina	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Osteopetrosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Congenital cystic kidney disease	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Basal cell naevus syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Congenital, familial and genetic disorders Keratosis follicular	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Anaemia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Anaemia macrocytic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Iron deficiency anaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Coagulopathy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Blood disorder	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Haemolytic anaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Chronic lymphocytic leukaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Non-Hodgkin's lymphoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Gammopathy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Multiple myeloma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Lymphadenopathy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Lymphoedema	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Leukocytosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Leukopenia	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Blood and lymphatic system disorders Neutropenia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Carotid artery stenosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cerebral vasoconstriction	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cerebrovascular accident	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Haemorrhagic stroke	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Ischaemic stroke	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Temporal arteritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Transient ischaemic attack	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Anosmia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cranial nerve paralysis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Facial palsy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Facial spasm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Neuritis cranial	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Optic neuritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders VIth nerve paralysis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Multiple sclerosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Headache	5.7% 82/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	4.1% 61/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Migraine	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Migraine with aura	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Tension headache	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Amnesia	1.9% 27/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.9% 28/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Cognitive disorder	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dementia Alzheimer's type	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dementia of the Alzheimer's type, with depressed mood	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Disturbance in attention	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Memory impairment	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Essential tremor	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Parkinsonism	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Parkinson's disease	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Spastic paralysis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Torticollis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Tremor	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Ageusia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Analgesia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Aphonia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Balance disorder	2.4% 35/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.4% 35/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Confusional state	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Coordination abnormal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dizziness	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dizziness postural	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dysaesthesia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Dysgeusia	0.76% 11/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Hypoaesthesia	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Lethargy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Loss of consciousness	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Neuralgia	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Neurological symptom	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Paraesthesia	3.0% 43/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.5% 23/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Presyncope	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Restless legs syndrome	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Sensory disturbance	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Somnolence	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Syncope	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Vertigo	1.0% 15/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 17/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Muscle rigidity	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Carpal tunnel syndrome	2.4% 35/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.87% 13/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Guillain-Barre syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Nerve compression	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Neuropathy peripheral	1.2% 17/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.94% 14/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Convulsion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Epilepsy	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Insomnia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Narcolepsy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Radiculopathy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Nervous system disorders Sciatica	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Cataract	5.3% 77/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	4.3% 64/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Cataract congenital	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Cataract diabetic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Cataract nuclear	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Entropion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Corneal disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Dry eye	2.4% 35/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.3% 49/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Eye disorder	2.6% 38/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.4% 35/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Eye pain	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Eyelid disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Lacrimation increased	0.83% 12/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Vitreous disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Borderline glaucoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Glaucoma	1.4% 21/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.0% 15/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Ocular hypertension	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Conjunctival haemorrhage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Eye haemorrhage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Blepharitis	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Conjunctivitis	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Episcleritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Eye irritation	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Ocular hyperaemia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Haemangioma of retina	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Blepharospasm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Macular degeneration	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Macular hole	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal detachment	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal tear	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Vitreous detachment	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Diabetic retinopathy	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal artery occlusion	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal vein occlusion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Retinal vein thrombosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Blindness	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Diplopia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Myopia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Vision blurred	0.83% 12/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Visual acuity reduced	2.8% 40/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.8% 42/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Eye disorders Visual impairment	0.76% 11/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.94% 14/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Cholesteatoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Ear pain	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Deafness	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Hearing impaired	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Meniere's disease	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Tinnitus	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Vertigo	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Mastoid disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Mastoiditis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Middle ear adhesions	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Ear and labyrinth disorders Tympanic membrane perforation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal hernia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Femoral hernia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Hiatus hernia	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Inguinal hernia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Lumbar hernia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Anal fissure	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Anal pruritus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Anorectal disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Anorectal squamous cell metaplasia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Rectal prolapse	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Anal polyp	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colonic polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastric polyps	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Intestinal polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Rectal polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gingival disorder	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gingivitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Poor dental condition	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Tooth fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Toothache	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Diverticulitis	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Diverticulitis intestinal haemorrhagic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Diverticulum	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Barrett's oesophagus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Food poisoning	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastric disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastric mucosal hypertrophy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastrointestinal disorder	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Oesophageal disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Haematemesis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Haematochezia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Rectal haemorrhage	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Small intestinal haemorrhage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colitis ischaemic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Colitis ulcerative	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastritis	0.83% 12/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.87% 13/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastrointestinal inflammation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Inflammatory bowel disease	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Oesophagitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Proctocolitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Reflux oesophagitis	1.2% 17/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Change of bowel habit	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Constipation	1.7% 24/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.8% 42/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Diarrhoea	1.4% 20/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Duodenogastric reflux	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Irritable bowel syndrome	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal distension	1.0% 15/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal mass	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal pain	2.3% 33/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.2% 48/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Dyspepsia	1.7% 25/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.6% 24/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Dysphagia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Epigastric discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Flatulence	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Nausea	3.9% 57/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.4% 51/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Pelvic pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Vomiting	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gallstone ileus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Intestinal obstruction	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Gastric ulcer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Large intestine perforation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Haemorrhoids	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Coeliac disease	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Anal cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Rectal cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Mouth ulceration	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Oral pain	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Stomatitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Abdominal adhesions	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Dry mouth	1.7% 25/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 16/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Dry throat	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Lip dry	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Salivary gland cyst	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Salivary gland disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Ageusia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Glossitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Gastrointestinal disorders Tongue disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Bladder disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Bladder prolapse	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Calculus bladder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Chromaturia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Cystitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Dysuria	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Haematuria	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Haemorrhage urinary tract	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Micturition disorder	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 16/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Micturition urgency	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Nephrolithiasis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Nocturia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Pollakiuria	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Polyuria	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal colic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal failure chronic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Renal tubular acidosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Stress urinary incontinence	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Urethral stenosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Urinary incontinence	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.0% 15/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Renal and urinary disorders Urinary tract infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Acne	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Actinic keratosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Alopecia	5.5% 80/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	6.2% 93/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Alopecia areata	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Basal cell carcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Basal cell naevus syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Blister	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Bowen's disease	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Cellulitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Dermal cyst	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Dermatomyositis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Dry skin	1.9% 27/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.9% 28/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Eczema	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Erythema multiforme	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Erythema nodosum	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Hair colour changes	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Hair disorder	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Hirsutism	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Hyperhidrosis	1.7% 25/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Lichen planus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Lichen sclerosus	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Morphoea	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Nail disorder	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.87% 13/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Night sweats	21.4% 310/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	22.9% 341/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Onychoclasis	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 16/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Periorbital oedema	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Pigmentation disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Pruritus	1.5% 22/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.6% 38/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Pruritus generalised	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Psoriasis	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Rash	1.8% 26/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.5% 37/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Rash scarlatiniform	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Rosacea	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Scar	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Scar pain	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin atrophy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin disorder	0.83% 12/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin mass	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin swelling	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin ulcer	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Skin warm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Superficial spreading melanoma stage unspecified	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Swelling face	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Telangiectasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Urticaria	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Varicella	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Skin and subcutaneous tissue disorders Vitiligo	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Bone erosion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Exostosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Jaw disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteitis deformans	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteonecrosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteopenia	0.76% 11/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteoporosis	7.3% 106/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	4.8% 71/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteoporosis postmenopausal	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Pain in jaw	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Spinal disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders CREST syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Morphoea	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Scleroderma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Sjogren's syndrome	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Ankle fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Clavicle fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Fibula fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Foot fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Forearm fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Fractured coccyx	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Hand fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Hip fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Humerus fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Lower limb fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Pathological fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Radius fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Rib fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Spinal fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Thoracic vertebral fracture	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Upper limb fracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Wrist fracture	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Ankylosing spondylitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthralgia	58.1% 842/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	50.2% 748/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthritis	3.6% 52/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.4% 50/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthritis bacterial	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthritis infective	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthritis reactive	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Arthropathy	0.76% 11/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Floating patella	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Joint dislocation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Joint effusion	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Joint stiffness	5.1% 74/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.5% 37/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Joint swelling	1.2% 18/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 17/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Osteoarthritis	4.6% 67/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.6% 53/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Palindromic rheumatism	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Periarthritis	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	1.0% 15/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Senile ankylosing vertebral hyperostosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Spondylitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Fibromyalgia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Muscle atrophy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Muscle spasms	1.8% 26/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	7.3% 108/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Myalgia	8.6% 124/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	7.1% 106/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Periodic limb movement disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Torticollis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Trismus	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Foot deformity	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Lumbar spine flattening	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Sciatica	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Scoliosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Back disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Back pain	5.7% 82/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	6.8% 101/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Limb discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.9% 100/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	6.4% 95/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.3% 19/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Neck mass	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Pain in extremity	7.0% 101/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	5.4% 80/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Bunion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Bursitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Synovial cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Cartilage injury	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Costochondritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Tendonitis	1.2% 18/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Tenosynovitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Trigger finger	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Musculoskeletal and connective tissue disorders Breast cancer	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Adrenal adenoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Adrenal carcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Adrenal disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Adrenal mass	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Diabetes mellitus	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Type 2 diabetes mellitus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Hypoparathyroidism	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Parathyroid disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Goitre	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Hyperthyroidism	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Hypothyroidism	0.83% 12/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 16/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Thyroid cyst	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Endocrine disorders Thyroid disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Renal tubular acidosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Decreased appetite	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Increased appetite	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Weight fluctuation	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Bone metabolism disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Osteopenia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Osteoporosis	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Diabetic foot	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Fluid retention	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hyperkalaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hypokalaemia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hyponatraemia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Diabetes mellitus	1.4% 21/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.87% 13/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Haemochromatosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Iron deficiency anaemia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Iron overload	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hypercholesterolaemia	3.2% 47/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hyperlipidaemia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Goitre	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Hypothyroidism	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Gout	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Folate deficiency	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Multi-vitamin deficiency	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Vitamin B6 deficiency	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Metabolism and nutrition disorders Vitamin D deficiency	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Subacute sclerosing panencephalitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Bacterial infection	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Breast cellulitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Cellulitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Folliculitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Helicobacter gastritis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Helicobacter infection	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Lyme disease	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Staphylococcal infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Fungal infection	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Oral candidiasis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pneumonia cryptococcal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Vulvovaginal candidiasis	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.8% 42/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Acute sinusitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Arthritis infective	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Breast abscess	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Bronchiectasis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Chronic sinusitis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Cystitis	0.97% 14/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.94% 14/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Diverticulitis	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Eye infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Furuncle	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Gastroenteritis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Hordeolum	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Incision site infection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Labyrinthitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Liver abscess	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Localised infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Lower respiratory tract infection	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.94% 14/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Lung infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Mastitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Otitis externa	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Otitis media	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Paronychia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pharyngitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Pneumonia	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Post procedural infection	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Respiratory tract infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Rhinitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Sepsis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Sialoadenitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Sinusitis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Skin infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Tonsillitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Tooth abscess	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Upper respiratory tract infection	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Urinary tract infection	1.6% 23/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.1% 32/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Wound infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Mycobacterial infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Tuberculosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Toxoplasmosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Hepatitis viral	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Herpes simplex	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Herpes zoster	0.76% 11/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.87% 13/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Influenza	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.94% 14/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Post viral fatigue syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Vestibular neuronitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Infections and infestations Viral infection	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Accelerated hypertension	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Aneurysm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Angina unstable	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Aortic stenosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Carotid artery occlusion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Carotid artery stenosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Cerebrovascular accident	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Circulatory collapse	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Coronary artery disease	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Deep vein thrombosis	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Dizziness	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Embolism	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Epistaxis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Essential hypertension	4.7% 68/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.6% 54/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Femoral artery aneurysm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Haematoma	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Haemorrhage intracranial	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Hot flush	11.1% 161/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	12.4% 184/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Hypertension	1.9% 28/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.5% 22/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Hypotension	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Ischaemia	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Ischaemic stroke	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Lymphoedema	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Malignant hypertension	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Orthostatic hypotension	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Peripheral coldness	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Peripheral vascular disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Phlebitis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Postmenopausal haemorrhage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Presyncope	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Pulmonary embolism	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Spider vein	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Syncope	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Temporal arteritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Thrombophlebitis superficial	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Thrombosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Transient ischaemic attack	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Varicose ulceration	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Varicose vein	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Vasculitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Venous insufficiency	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Vascular disorders Venous thrombosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Abscess drainage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Acupuncture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Adrenal gland operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Anal polypectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Angioplasty	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Ankle operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Aortic valve replacement	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Appendicectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Arterial stent insertion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Arthroscopic surgery	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Bladder operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Bone lesion excision	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Bone operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Breast cyst drainage	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Breast lump removal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Breast reconstruction	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Bunion operation	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cancer surgery	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cardiac ablation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cardiac operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cardiac pacemaker insertion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cardiac resynchronisation therapy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cardioversion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Carpal tunnel decompression	0.90% 13/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cataract operation	1.2% 18/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.7% 26/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cervical polypectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Chemotherapy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Chiropractic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cholecystectomy	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Colon operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Colon polypectomy	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Colonoscopy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Colostomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Colporrhaphy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Coronary artery bypass	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Cyst removal	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Debridement	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Dental care	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Dental implantation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Dupuytren's contracture operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Ear operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Elbow operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Elective surgery	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Emergency care	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Endocervical curettage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Ethmoid sinus surgery	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Eye operation	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Foot operation	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Gallbladder operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Haemorrhoid operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hand repair operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Heart valve replacement	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hernia repair	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures High frequency ablation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hip arthroplasty	0.97% 14/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hip surgery	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hospitalisation	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Hysterectomy	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.1% 17/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Ileostomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Incisional hernia repair	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Inguinal hernia repair	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Intervertebral disc operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Intestinal resection	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Intraocular lens implant	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Intra-uterine contraceptive device	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Jaw operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Joint manipulation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Joint surgery	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Knee arthroplasty	0.83% 12/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.87% 13/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Knee operation	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Large intestine operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Laryngeal polypectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Lesion excision	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Limb operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Lipoma excision	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Local anaesthesia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Lung lobectomy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Lymphadenectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Mammoplasty	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Mastectomy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Meningioma surgery	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Meniscus removal	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Mitral valve replacement	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Mole excision	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Muscle operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Nail operation	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Nasal operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Nephrectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Nerve block	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Oophorectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Oophorectomy bilateral	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Open reduction of fracture	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Ovarian cystectomy	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Parathyroidectomy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Pelvic floor repair	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Physiotherapy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Plastic surgery	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Polypectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Prolapse repair	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Prosthesis implantation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Radical mastectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Radiotherapy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Renal cyst excision	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Retinal laser coagulation	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Retinal operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Salpingectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Salpingo-oophorectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Salpingo-oophorectomy bilateral	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Sclerotherapy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Shoulder arthroplasty	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Shoulder operation	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Simple mastectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Sinus operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Skin graft	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Skin lesion excision	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Skin neoplasm excision	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Spinal decompression	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Spinal laminectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Spinal operation	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Stent placement	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Steroid therapy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Surgery	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Tendon operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Tendon sheath lesion excision	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Therapeutic skin care topical	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Thoracotomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Thyroid operation	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Thyroidectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Toe amputation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Toe operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Tooth extraction	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Trabeculectomy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Transfusion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Tumour excision	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Umbilical hernia repair	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine cervix dilation procedure	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine cystectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine dilation and curettage	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine polypectomy	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Uterine prolapse repair	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Varicose vein operation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Venous ligation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Venous operation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Surgical and medical procedures Vocal cordectomy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign breast neoplasm	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cyst	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibroadenoma of breast	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal polyp	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric polyps	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anal cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer stage IV	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal cancer metastatic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intestinal adenocarcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip and/or oral cavity cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Focal nodular hyperplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mesothelioma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to skin	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoma benign	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholesteatoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cyst	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenoid cystic carcinoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Angiosarcoma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma in situ	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of unknown primary site	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Recurrent cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intracranial meningioma malignant	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gammopathy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Genital cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervical polyp	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Degeneration of uterine fibroid	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cyst	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cyst	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine polyp	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vaginal polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage I	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign lung neoplasm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasal polyps	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell lung cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified recurrent	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage 0	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thymoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bowen's disease	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma in situ	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Superficial spreading melanoma stage unspecified	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Asthma	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Drug hypersensitivity	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Hypersensitivity	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.67% 10/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Multiple allergies	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Antiphospholipid syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Polymyalgia rheumatica	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Rheumatoid arthritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Polyarteritis nodosa	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Immune system disorders Temporal arteritis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Social circumstances Bereavement	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Social circumstances Ex-tobacco user	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Pyrexia	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Asthenia	1.6% 23/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.7% 25/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Axillary pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Chest discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Chest pain	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Chills	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Disease recurrence	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Facial pain	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Fatigue	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Gait disturbance	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Hernia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Hot flush	1.3% 19/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.94% 14/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Inflammation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Influenza like illness	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Irritability	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Lethargy	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Malaise	11.4% 165/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	11.9% 177/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Night sweats	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Oedema	1.4% 21/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.9% 28/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Oedema peripheral	1.2% 18/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Pain	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Polyp	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Thirst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Adverse drug reaction	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Adverse reaction	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Cyst	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Dysplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Fat necrosis	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Fibrosis	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
General disorders Hyperplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Agitation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Amnesia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Aggression	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Alcohol problem	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Anxiety	1.0% 15/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.5% 22/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Bipolar I disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Cognitive disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Depression	4.6% 67/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	4.7% 70/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Eating disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Emotional disorder	1.9% 27/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.4% 36/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Hallucination	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Insomnia	7.5% 109/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	6.2% 93/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Loss of libido	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Mental disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Nervousness	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Neurosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Nightmare	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Personality disorder	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Phobia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Restlessness	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Sleep disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Somnolence	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Stress	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Psychiatric disorders Suicidal ideation	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Adnexa uteri pain	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Arthritis climacteric	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Benign breast neoplasm	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast abscess	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast calcifications	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast cancer in situ	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast cancer metastatic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast cancer recurrent	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast cyst	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast discharge	0.41% 6/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast discomfort	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast disorder	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast hyperplasia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast infection	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast necrosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast pain	4.8% 70/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	4.4% 66/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Breast swelling	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Cervical dysplasia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Cervical polyp	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Cystocele	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Dysmenorrhoea	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Dyspareunia	0.76% 11/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometrial disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometrial hyperplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.2% 18/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometrial hypertrophy	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.3% 34/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Endometriosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Fibrocystic breast disease	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Galactorrhoea	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Gynaecomastia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Hot flush	56.2% 815/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	60.3% 898/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Intraductal papilloma of breast	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Mastitis	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Menopausal symptoms	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Menorrhagia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Metrorrhagia	0.90% 13/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.3% 20/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Night sweats	4.8% 70/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	5.0% 74/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Nipple disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Nipple pain	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Ovarian cyst	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.60% 9/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Ovarian mass	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Pelvic pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Perineal pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Postmenopausal haemorrhage	0.90% 13/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Premenstrual syndrome	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Sexual dysfunction	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine atrophy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine cyst	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine fibrosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine leiomyoma	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine polyp	0.62% 9/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.7% 25/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine prolapse	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Uterine spasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal cyst	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal discharge	2.1% 31/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	9.4% 140/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal disorder	1.4% 20/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.5% 22/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal haemorrhage	2.2% 32/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	5.2% 78/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal inflammation	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal polyp	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal prolapse	0.55% 8/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.74% 11/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vaginal swelling	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vulval abscess	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vulval neoplasm	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vulval polyp	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vulvovaginal dryness	13.9% 201/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	11.1% 166/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vulvovaginal pain	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Reproductive system and breast disorders Vulvovaginal pruritus	1.3% 19/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.2% 47/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Asthma	0.69% 10/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.81% 12/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Chest discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Chest pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.40% 6/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Cough	1.1% 16/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.6% 24/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Dry throat	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 21/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	2.0% 30/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Emphysema	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.35% 5/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Lobar pneumonia	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Lower respiratory tract infection	1.5% 22/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	3.6% 53/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Lung cancer metastatic	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Multifocal micronodular pneumocyte hyperplasia	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pertussis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pleurisy	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pneumonia	0.48% 7/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.27% 4/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.14% 2/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.34% 5/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Sinusitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	1.7% 24/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	1.7% 25/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Throat tightness	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Tonsillar disorder	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Tonsillitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.47% 7/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholecystitis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholecystitis acute	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholecystitis chronic	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Cholelithiasis	0.28% 4/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.54% 8/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Gallbladder disorder	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Haemochromatosis	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.13% 2/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Hepatic cirrhosis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.00% 0/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Hepatitis	0.07% 1/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Liver disorder	0.21% 3/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.20% 3/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Hepatobiliary disorders Hepatobiliary carcinoma in situ	0.00% 0/1449 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).	0.07% 1/1489 • Adverse event data were collected from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Additional Information

Professor Jack Cuzick

Queen Mary University of London

Phone: +442078823504

Email: j.cuzick@qmul.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee Individual sites have statements of agreement that outline disclosure restrictions.
• Publication restrictions are in place

Restriction type: OTHER