Trial Outcomes & Findings for Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction (NCT NCT02929329)

NCT ID: NCT02929329

Last Updated: 2021-11-05

Results Overview

The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis. A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy. All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials. Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 8256 participants
• Primary outcome timeframe: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
• Results posted on: 2021-11-05

Participant Flow

A total of 11,121 patients underwent screening at 944 sites in 35 countries. Of these patients, 8,256 were randomized, but 24 patients from one site were excluded because of Good Clinical Practice violations and are not included in the data reported below.

Participants were randomly assigned in a 1:1 ratio to receive either oral omecamtiv mecarbil (OM) or placebo. Randomization was stratified by randomization setting (currently hospitalized for heart failure [HF] or recently and not currently hospitalized for HF) and region (United States and Canada; Latin America; Western Europe, South Africa, and Australasia; Eastern Europe including Russia; Asia).

Participant milestones

Measure	Placebo Participants received matching placebo tablets twice a day (BID).	Omecamtiv Mecarbil Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Overall Study STARTED	4112	4120
Overall Study Received Treatment	4101	4110
Overall Study COMPLETED	3008	3028
Overall Study NOT COMPLETED	1104	1092

Reasons for withdrawal

Measure	Placebo Participants received matching placebo tablets twice a day (BID).	Omecamtiv Mecarbil Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Overall Study Withdrawal by Subject	24	21
Overall Study Lost to Follow-up	26	20
Overall Study Death	1054	1051

Baseline Characteristics

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

Baseline characteristics by cohort

Measure	Placebo n=4112 Participants Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=4120 Participants Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.	Total n=8232 Participants Total of all reporting groups
Age, Continuous	64.5 years STANDARD_DEVIATION 11.4 • n=5 Participants	64.5 years STANDARD_DEVIATION 11.3 • n=7 Participants	64.5 years STANDARD_DEVIATION 11.4 • n=5 Participants
Age, Customized 18 to 64 years	1873 Participants n=5 Participants	1874 Participants n=7 Participants	3747 Participants n=5 Participants
Age, Customized 65 to 84 years	2211 Participants n=5 Participants	2220 Participants n=7 Participants	4431 Participants n=5 Participants
Age, Customized 85 years and over	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Female	874 Participants n=5 Participants	875 Participants n=7 Participants	1749 Participants n=5 Participants
Sex: Female, Male Male	3238 Participants n=5 Participants	3245 Participants n=7 Participants	6483 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	885 Participants n=5 Participants	886 Participants n=7 Participants	1771 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3227 Participants n=5 Participants	3234 Participants n=7 Participants	6461 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	38 Participants n=5 Participants	35 Participants n=7 Participants	73 Participants n=5 Participants
Race/Ethnicity, Customized Asian	355 Participants n=5 Participants	355 Participants n=7 Participants	710 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	277 Participants n=5 Participants	285 Participants n=7 Participants	562 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	96 Participants n=5 Participants	99 Participants n=7 Participants	195 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized White	3201 Participants n=5 Participants	3196 Participants n=7 Participants	6397 Participants n=5 Participants
Race/Ethnicity, Customized Other	139 Participants n=5 Participants	143 Participants n=7 Participants	282 Participants n=5 Participants
Randomization Setting Currently hospitalized for heart failure	1050 Participants n=5 Participants	1051 Participants n=7 Participants	2101 Participants n=5 Participants
Randomization Setting Recently and not currently hospitalized for heart failure	3062 Participants n=5 Participants	3069 Participants n=7 Participants	6131 Participants n=5 Participants
Region United States and Canada	693 Participants n=5 Participants	693 Participants n=7 Participants	1386 Participants n=5 Participants
Region Latin America	787 Participants n=5 Participants	787 Participants n=7 Participants	1574 Participants n=5 Participants
Region Western Europe, South Africa, and Australasia	960 Participants n=5 Participants	961 Participants n=7 Participants	1921 Participants n=5 Participants
Region Eastern Europe including Russia	1337 Participants n=5 Participants	1344 Participants n=7 Participants	2681 Participants n=5 Participants
Region Asia	335 Participants n=5 Participants	335 Participants n=7 Participants	670 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Population: Full analysis set

The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis.

A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy.

All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials.

Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.

Outcome measures

Measure	Placebo n=4112 Participants Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=4120 Participants Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.	Placebo: Inpatients Participants who were currently hospitalized for heart failure received placebo tablets twice a day.	Omecamtiv Mecarbil: Inpatients Participants who were currently hospitalized for heart failure received oral omecamtiv mecarbil twice daily. The starting dose was 25 mg; the dose could be adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Time to Cardiovascular Death or First Heart Failure Event	39.1 percentage of participants	37.0 percentage of participants	—	—

SECONDARY outcome

Timeframe: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Population: Full analysis set

Cardiovascular death includes acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.

All deaths were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.

Time to cardiovascular death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.

Outcome measures

Measure	Placebo n=4112 Participants Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=4120 Participants Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.	Placebo: Inpatients Participants who were currently hospitalized for heart failure received placebo tablets twice a day.	Omecamtiv Mecarbil: Inpatients Participants who were currently hospitalized for heart failure received oral omecamtiv mecarbil twice daily. The starting dose was 25 mg; the dose could be adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Time to Cardiovascular Death	19.4 percentage of participants	19.6 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: Full analysis set with available data

The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire with a 2-week recall period that includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where lower scores represent more frequent and severe symptoms and scores of 100 indicate no symptoms.

The change from baseline in KCCQ TSS was analyzed separately for each randomization setting (inpatient and outpatient).

Least squares means are from the mixed model which includes baseline total symptom score value, region, baseline eGFR, scheduled visit, treatment group and interaction of treatment with scheduled visit as covariates.

Outcome measures

Measure	Placebo n=2704 Participants Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=2715 Participants Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.	Placebo: Inpatients n=835 Participants Participants who were currently hospitalized for heart failure received placebo tablets twice a day.	Omecamtiv Mecarbil: Inpatients n=868 Participants Participants who were currently hospitalized for heart failure received oral omecamtiv mecarbil twice daily. The starting dose was 25 mg; the dose could be adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24	6.29 scores on a scale Standard Error 0.34	5.83 scores on a scale Standard Error 0.34	21.15 scores on a scale Standard Error 0.71	23.65 scores on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Population: Full analysis set

A HF hospitalization is defined as an event that met all of the following criteria:

1. The participant was admitted to the hospital with a primary diagnosis of HF;

2. The length of stay in the hospital extended for at least 24 hours;

3. The participant exhibited documented new or worsening symptoms due to HF on presentation;

4. The participant had objective evidence of new or worsening HF;

5. The participant received initiation or intensification of treatment specifically for HF, including an intravenous diuretic or vasoactive agent, mechanical or surgical intervention, or mechanical fluid removal.

Events were adjudicated by an independent external CEC at the Duke Clinical Research Institute using standardized definitions based on the ACC/AHA standards for endpoint definitions in CV clinical trials.

Time to first HF hospitalization was analyzed using KM methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event is reported.

Outcome measures

Measure	Placebo n=4112 Participants Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=4120 Participants Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.	Placebo: Inpatients Participants who were currently hospitalized for heart failure received placebo tablets twice a day.	Omecamtiv Mecarbil: Inpatients Participants who were currently hospitalized for heart failure received oral omecamtiv mecarbil twice daily. The starting dose was 25 mg; the dose could be adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Time to First Heart Failure Hospitalization	28.7 percentage of participants	27.7 percentage of participants	—	—

SECONDARY outcome

Timeframe: From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Population: Full analysis set

All events were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.

Time to all-cause death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with an event are reported. Events that occurred up to the earliest of last confirmed survival status date or analysis cut-off date (07 August 2020) are included.

Outcome measures

Measure	Placebo n=4112 Participants Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=4120 Participants Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.	Placebo: Inpatients Participants who were currently hospitalized for heart failure received placebo tablets twice a day.	Omecamtiv Mecarbil: Inpatients Participants who were currently hospitalized for heart failure received oral omecamtiv mecarbil twice daily. The starting dose was 25 mg; the dose could be adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Time to All-cause Death	25.9 percentage of participants	25.9 percentage of participants	—	—

Adverse Events

Placebo

Serious events: 2435 serious events

Other events: 1146 other events

Deaths: 1078 deaths

Omecamtiv Mecarbil

Serious events: 2373 serious events

Other events: 1129 other events

Deaths: 1078 deaths

Serious adverse events

Measure	Placebo n=4101 participants at risk Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=4110 participants at risk Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Cardiac disorders Sinus node dysfunction	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia	0.68% 28/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.83% 34/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia of chronic disease	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Anaemia vitamin B12 deficiency	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Blood loss anaemia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Cold type haemolytic anaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Hypercoagulation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Hypochromic anaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Iron deficiency anaemia	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Leukopenia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus tachycardia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Microcytic anaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Neutropenia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Normochromic anaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Normocytic anaemia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Pancytopenia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Splenic infarction	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Spontaneous haematoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute coronary syndrome	0.29% 12/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.27% 11/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute left ventricular failure	0.39% 16/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute myocardial infarction	1.6% 64/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.7% 71/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Acute right ventricular failure	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Angina pectoris	0.98% 40/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.00% 41/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Angina unstable	1.2% 49/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.5% 63/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Aortic valve disease	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Aortic valve disease mixed	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Aortic valve incompetence	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Aortic valve stenosis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Arrhythmia	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Arrhythmia supraventricular	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Arteriosclerosis coronary artery	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial fibrillation	2.8% 113/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.3% 94/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial flutter	0.61% 25/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.56% 23/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial tachycardia	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrial thrombosis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block complete	0.29% 12/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 14/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Impaired healing	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Atrioventricular block second degree	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Bradyarrhythmia	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Bradycardia	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Bundle branch block left	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac amyloidosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac aneurysm	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	1.6% 64/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.2% 50/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac asthma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac disorder	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure	25.5% 1045/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	24.0% 988/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure acute	6.1% 251/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.2% 212/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure chronic	4.1% 170/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.8% 156/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure congestive	3.8% 154/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.6% 147/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac flutter	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac tamponade	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac valve disease	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiac ventricular thrombosis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardio-respiratory arrest	0.34% 14/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiogenic shock	1.7% 68/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.8% 75/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiomyopathy	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.29% 12/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiopulmonary failure	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiorenal syndrome	0.24% 10/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 14/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Cardiovascular insufficiency	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Chordae tendinae rupture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Chronic left ventricular failure	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Chronotropic incompetence	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Conduction disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Congestive cardiomyopathy	0.59% 24/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 14/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery disease	0.59% 24/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.63% 26/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery insufficiency	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery occlusion	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Coronary artery stenosis	0.24% 10/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Extrasystoles	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Hypertensive heart disease	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Intracardiac thrombus	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ischaemic cardiomyopathy	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Left ventricular dysfunction	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Left ventricular failure	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Low cardiac output syndrome	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Mitral valve incompetence	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Myocardial fibrosis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Myocardial infarction	1.3% 54/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.88% 36/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Myocardial ischaemia	0.24% 10/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.29% 12/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Myocarditis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Paroxysmal arrhythmia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericardial haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericarditis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pericarditis constrictive	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Postinfarction angina	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Prinzmetal angina	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Prosthetic cardiac valve thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Pulseless electrical activity	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Right ventricular dysfunction	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Right ventricular failure	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus arrest	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Sinus bradycardia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular extrasystoles	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular tachyarrhythmia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.27% 11/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tachyarrhythmia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Tricuspid valve incompetence	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Trifascicular block	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular arrhythmia	0.44% 18/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.58% 24/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular extrasystoles	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular fibrillation	1.2% 49/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.73% 30/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular flutter	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular tachyarrhythmia	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Cardiac disorders Ventricular tachycardia	3.1% 129/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	2.6% 106/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Congenital megaureter	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Hydrocele	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Myocardial bridging	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Congenital, familial and genetic disorders Non-compaction cardiomyopathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Deafness unilateral	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Sudden hearing loss	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo positional	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Basedow's disease	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Goitre	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Hypercalcaemia of malignancy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Hyperthyroidism	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Hypothyroidism	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Thyroiditis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Endocrine disorders Thyrotoxic crisis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Amaurosis fugax	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Arteriosclerotic retinopathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Cataract	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Cataract diabetic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Diabetic retinopathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Diplopia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Eye inflammation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Glaucoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Iridodialysis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Iris disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Macular fibrosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Ocular hypertension	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Pterygium	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Retinal detachment	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Scleromalacia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Ulcerative keratitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Visual impairment	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Vitreous haematoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Eye disorders Vitreous haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal adhesions	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal discomfort	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal hernia	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal incarcerated hernia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.32% 13/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Abnormal faeces	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Acute abdomen	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Anal fistula	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Anorectal disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Ascites	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Chronic gastritis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis ischaemic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis microscopic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Crohn's disease	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diabetic gastroparesis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.29% 12/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dieulafoy's vascular malformation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticular perforation	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Duodenitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Dysphagia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Enterocolitis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Epiploic appendagitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Erosive oesophagitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Food poisoning	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric polyps	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric ulcer perforation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis erosive	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastritis haemorrhagic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal angiodysplasia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.34% 14/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.44% 18/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal necrosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Gingival bleeding	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haematemesis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haematochezia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemoperitoneum	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhagic erosive gastritis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Hernial eventration	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Hiatus hernia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Ileus	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Ileus paralytic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Incarcerated umbilical hernia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.24% 10/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Inguinal hernia strangulated	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal angina	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal haemorrhage	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal infarction	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal ischaemia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Incarcerated hernia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intestinal perforation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Intussusception	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Irritable bowel syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Ischaemic enteritis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestine perforation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Large intestine polyp	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Lower gastrointestinal perforation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Mechanical ileus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Melaena	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric arterial occlusion	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric artery embolism	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Mesenteric vascular insufficiency	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Necrotising oesophagitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Obstructive pancreatitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal motility disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal spasm	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Oesophagitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis acute	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatitis haemorrhagic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Pancreatolithiasis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Peptic ulcer haemorrhage	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal fissure	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal haemorrhage	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal polyp	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Rectal prolapse	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Small intestinal obstruction	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Subileus	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Thrombosis mesenteric vessel	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Tooth disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Umbilical hernia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.24% 10/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Volvulus	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Asthenia	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Cardiac death	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Catheter site haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest discomfort	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Chest pain	0.54% 22/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.36% 15/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Complication associated with device	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Death	1.2% 49/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.6% 65/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Discomfort	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Drug withdrawal syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Fatigue	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Gait disturbance	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Gait inability	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders General physical health deterioration	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Generalised oedema	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Hypothermia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Inflammation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Influenza like illness	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Infusion site extravasation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Localised oedema	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Malaise	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Medical device site haematoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Medical device site haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Medical device site thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Multiple organ dysfunction syndrome	0.34% 14/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.41% 17/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Nodule	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Non-cardiac chest pain	0.66% 27/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.80% 33/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Oedema peripheral	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pacemaker generated arrhythmia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pain	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Performance status decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Peripheral swelling	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Physical deconditioning	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pneumatosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Pyrexia	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Sudden cardiac death	0.90% 37/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.66% 27/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Sudden death	1.4% 58/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.3% 52/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Swelling face	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Systemic inflammatory response syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Ulcer haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Vascular stent occlusion	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Vascular stent stenosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
General disorders Vessel puncture site haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Acute hepatic failure	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Alcoholic liver disease	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Autoimmune hepatitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Bile duct obstruction	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Bile duct stone	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Biliary colic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cardiac cirrhosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholangitis acute	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.27% 11/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis acute	0.44% 18/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.27% 11/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholecystitis chronic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis	0.27% 11/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholelithiasis obstructive	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cholestasis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Cirrhosis alcoholic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Congestive hepatopathy	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Drug-induced liver injury	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic cirrhosis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic failure	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic haematoma	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatic ischaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatitis acute	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatocellular injury	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatorenal failure	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatorenal syndrome	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Hepatotoxicity	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Ischaemic hepatitis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Jaundice cholestatic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Liver disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Liver injury	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Portal hypertension	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Portal vein thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Primary biliary cholangitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Hepatobiliary disorders Venoocclusive liver disease	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Anaphylactic shock	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Drug hypersensitivity	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Heart transplant rejection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Immune system disorders Hypersensitivity	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Abdominal sepsis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Abscess jaw	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Abscess limb	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Acute endocarditis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Acute hepatitis B	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Anal abscess	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Appendiceal abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Appendicitis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Appendicitis perforated	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Arteriosclerotic gangrene	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Arthritis bacterial	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Atypical pneumonia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacteraemia	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacterial infection	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacterial sepsis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bacterial tracheitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Biliary sepsis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	0.59% 24/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.61% 25/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchitis bacterial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchitis viral	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Burn infection	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Bursitis infective staphylococcal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations COVID-19 pneumonia	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Catheter bacteraemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Catheter site infection	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cellulitis	0.59% 24/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.83% 34/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Chagas' cardiomyopathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cholecystitis infective	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Chronic sinusitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Citrobacter sepsis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Clostridial infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Clostridial sepsis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile infection	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Complicated appendicitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Conjunctivitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Cystitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Dengue fever	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Device related infection	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Device related sepsis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diabetic foot infection	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diabetic gangrene	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diarrhoea infectious	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Diverticulitis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Eczema infected	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Embolic pneumonia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Empyema	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Encephalitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Endocarditis	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Endocarditis bacterial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Endocarditis enterococcal	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterobacter bacteraemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterococcal bacteraemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterococcal infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterocolitis bacterial	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Enterocolitis viral	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Epididymitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Erysipelas	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.24% 10/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Escherichia infection	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Escherichia urinary tract infection	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Fournier's gangrene	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Fungal infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gallbladder abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gangrene	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gas gangrene	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.27% 11/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.36% 15/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis bacterial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis norovirus	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis viral	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Gastrointestinal viral infection	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Graft infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Groin abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Hepatitis A	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Hepatitis viral	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Herpes dermatitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Herpes virus infection	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Herpes zoster	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Implant site infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Incision site abscess	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infected seroma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infected skin ulcer	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infection	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infectious pleural effusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infective myositis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Infective spondylitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Influenza	0.37% 15/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 19/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Intervertebral discitis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Jejunal gangrene	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Kidney infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Klebsiella bacteraemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Klebsiella sepsis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Labyrinthitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Large intestine infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Laryngitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Liver abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Localised infection	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection viral	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lung abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Lymphadenitis bacterial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Mediastinitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Medical device site infection	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Meningitis bacterial	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Metapneumovirus infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Myiasis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Necrotising fasciitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Ophthalmic herpes zoster	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Orchitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Osteomyelitis	0.29% 12/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Osteomyelitis acute	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Osteomyelitis bacterial	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Osteomyelitis chronic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Otitis media bacterial	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Parainfluenzae virus infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Peritonitis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Peritonitis bacterial	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Peritonsillar abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pharyngitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pilonidal cyst	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumococcal sepsis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	4.4% 179/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.2% 171/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia adenoviral	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia bacterial	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia escherichia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia haemophilus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia influenzal	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia klebsiella	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia moraxella	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia mycoplasmal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia necrotising	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia pneumococcal	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia respiratory syncytial viral	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia staphylococcal	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pneumonia viral	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Postoperative wound infection	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Prostatic abscess	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pseudomembranous colitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pulmonary sepsis	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pulmonary tuberculosis	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pyelonephritis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Pyelonephritis acute	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Respiratory syncytial virus infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.59% 24/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.36% 15/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection bacterial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection fungal	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection viral	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Scrotal abscess	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sepsis	1.5% 60/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.2% 51/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sepsis syndrome	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Septic shock	0.78% 32/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.90% 37/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sinusitis bacterial	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Skin graft infection	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Skin infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Soft tissue infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Staphylococcal bacteraemia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Staphylococcal infection	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Staphylococcal sepsis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Sternitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Stitch abscess	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Streptococcal bacteraemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Streptococcal endocarditis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tooth abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tooth infection	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tracheitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tracheobronchitis	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tuberculoma of central nervous system	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Tuberculosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	0.27% 11/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 14/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.78% 32/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.80% 33/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection bacterial	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection enterococcal	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urinary tract infection staphylococcal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urogenital infection bacterial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Urosepsis	0.37% 15/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Vascular device infection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Viraemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Viral infection	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Viral upper respiratory tract infection	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Wound abscess	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Wound infection	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Wound infection bacterial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Wound infection staphylococcal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Infections and infestations Wound sepsis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Abdominal wound dehiscence	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Accidental exposure to product by child	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Accidental overdose	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Alcohol poisoning	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Ankle fracture	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Arterial bypass thrombosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Bone contusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Brain contusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Burns third degree	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Carbon monoxide poisoning	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Cardiac procedure complication	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Cardiac vein perforation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Cataract traumatic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Concussion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Contusion	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Dialysis disequilibrium syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Epidural haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Eschar	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Facial bones fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fall	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.24% 10/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femoral neck fracture	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Femur fracture	0.34% 14/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.27% 11/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Foot fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Foreign body in eye	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Foreign body in gastrointestinal tract	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fracture displacement	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Fractured coccyx	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Gastrostomy tube site complication	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Graft thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Haematuria traumatic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hand fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Head injury	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hip fracture	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Humerus fracture	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Hyphaema	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Incisional hernia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Injury	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Injury corneal	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Intentional overdose	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Intestinal anastomosis complication	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Joint injury	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb crushing injury	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Limb traumatic amputation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Lower limb fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Meniscus injury	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Multiple injuries	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Osteophyte fracture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Overdose	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Patella fracture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Pelvic fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Periorbital haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Pneumocephalus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Pneumothorax traumatic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural fever	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haematuria	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Post procedural hypotension	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Postpericardiotomy syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural pneumothorax	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Radius fracture	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Rib fracture	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Scrotal haematoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skin laceration	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skull fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Skull fractured base	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal compression fracture	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Synovial rupture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tendon injury	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tendon rupture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Thermal burn	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Tibia fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Toxicity to various agents	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic haematoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Traumatic intracranial haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Upper limb fracture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Urethral injury	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular graft complication	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular graft occlusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular procedure complication	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vasoplegia syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Vena cava injury	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound complication	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wrist fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Anticoagulation drug level above therapeutic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Anticoagulation drug level below therapeutic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood alkaline phosphatase increased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood calcium decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood creatinine increased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood glucose decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood magnesium decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Blood potassium decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Cardiac output decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Catheterisation cardiac	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Coagulation time prolonged	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Ejection fraction decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Electrocardiogram QT prolonged	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Electrocardiogram ST segment elevation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations HIV antibody positive	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Haemoglobin decreased	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Hepatic enzyme abnormal	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Hepatic enzyme increased	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Influenza A virus test positive	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations International normalised ratio abnormal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations International normalised ratio decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations International normalised ratio increased	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Liver function test abnormal	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Liver function test increased	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Oxygen consumption increased	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations SARS-CoV-2 test positive	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Staphylococcus test positive	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Transaminases increased	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Transplant evaluation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Troponin increased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Investigations Weight decreased	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Abnormal loss of weight	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Acidosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Cachexia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Dehydration	0.37% 15/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.46% 19/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.36% 15/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic ketosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Electrolyte imbalance	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Failure to thrive	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Fluid overload	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Fluid retention	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Folate deficiency	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Gout	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 14/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.27% 11/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	0.51% 21/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 20/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperosmolar state	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypervolaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypocalcaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	0.32% 13/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.32% 13/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemic syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	0.46% 19/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 14/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypophagia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypovolaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Lactic acidosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Latent autoimmune diabetes in adults	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Malnutrition	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Metabolic alkalosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Obesity	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthropathy	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bursitis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Compartment syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Costochondritis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Elbow deformity	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Facial asymmetry	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Fasciitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Flank pain	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Gouty arthritis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc compression	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Limb discomfort	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Mobility decreased	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.24% 10/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myofascial pain syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.22% 9/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.29% 12/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteochondritis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteolysis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Osteoporotic fracture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Polyarthritis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Polymyalgia rheumatica	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spinal pain	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Spondylitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Vertebral foraminal stenosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell lung cancer stage III	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adrenal adenoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basosquamous carcinoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of testis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder adenocarcinoma stage 0	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone sarcoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Scrotal oedema	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Essential thrombocythaemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer metastatic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal stromal tumour	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hypopharyngeal cancer	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Metabolic encephalopathy	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive ductal breast carcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Laryngeal squamous cell carcinoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Liposarcoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage II	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage III	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung carcinoma cell type unspecified stage IV	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphangiosis carcinomatosa	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mediastinum neoplasm	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanoma recurrent	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic bronchial carcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic neoplasm	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelofibrosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Nasopharyngeal cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm skin	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine carcinoma of the skin	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neuroendocrine tumour of the lung metastatic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer stage IV	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal adenocarcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal neoplasm	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal squamous cell carcinoma stage IV	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Penile squamous cell carcinoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer recurrent	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage IV	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal neoplasm	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal neoplasm	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of pharynx	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the cervix	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid adenoma	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tonsil cancer	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ureteric cancer	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Alcohol induced persisting dementia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Altered state of consciousness	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Amnesia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Balance disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Brain compression	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Brain hypoxia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Brain injury	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Brain oedema	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Brain stem stroke	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Carotid arteriosclerosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Carotid artery disease	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Carotid artery occlusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Carotid artery stenosis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Carpal tunnel syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebellar haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral artery embolism	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral circulatory failure	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral haematoma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral haemorrhage	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral hypoperfusion	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral infarction	0.32% 13/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebral ischaemia	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.71% 29/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.61% 25/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cerebrovascular insufficiency	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Cognitive disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Coma	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Complex regional pain syndrome	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Diabetic neuropathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.20% 8/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness postural	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dysaesthesia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dysarthria	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Embolic stroke	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Epilepsy	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Generalised tonic-clonic seizure	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Haemorrhage intracranial	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Haemorrhagic cerebral infarction	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Haemorrhagic stroke	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Haemorrhagic transformation stroke	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Headache	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hemianopia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hemiparesis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hepatic encephalopathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hydrocephalus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hyperglycaemic unconsciousness	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Hypoglycaemic unconsciousness	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Ischaemic cerebral infarction	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Ischaemic stroke	0.93% 38/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.88% 36/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Lacunar infarction	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Lethargy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Loss of consciousness	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Meningism	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Mononeuritis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Monoplegia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Muscle contractions involuntary	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Myoclonus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Neuralgia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Neuromyopathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Normal pressure hydrocephalus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Orthostatic intolerance	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Parkinson's disease	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Partial seizures	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Peripheral sensorimotor neuropathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Polyneuropathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Post-traumatic epilepsy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Presyncope	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.19% 8/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Psychogenic seizure	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Psychomotor disadaptation syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Psychomotor hyperactivity	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Radicular pain	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Sciatica	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Sedation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Seizure	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Seizure like phenomena	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Status epilepticus	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Stroke in evolution	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Syncope	1.1% 46/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.0% 42/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Thrombotic stroke	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Transient ischaemic attack	0.59% 24/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.41% 17/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Trigeminal neuralgia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Vertebrobasilar insufficiency	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Vertigo CNS origin	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device alarm issue	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device dislocation	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device electrical impedance issue	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device extrusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device inappropriate shock delivery	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device lead damage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device lead issue	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device leakage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device malfunction	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device occlusion	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device physical property issue	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device power source issue	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device signal detection issue	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Device stimulation issue	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Lead dislodgement	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Oversensing	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Product Issues Undersensing	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Alcohol abuse	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Alcohol withdrawal syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Alcoholism	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Anxiety	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Anxiety disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Behaviour disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Bipolar disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Communication disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Completed suicide	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Confusional state	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Conversion disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Delirium	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Delusion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Depression	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Disorientation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Hallucination	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Major depression	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Mental disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Mental status changes	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Panic attack	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Personality disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Psychotic behaviour	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Suicidal ideation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Psychiatric disorders Suicide attempt	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Acute kidney injury	3.4% 138/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	3.1% 129/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Anuria	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Atonic urinary bladder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Azotaemia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Bladder neck obstruction	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Calculus bladder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Calculus urinary	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Chronic kidney disease	0.88% 36/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.88% 36/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Diabetic nephropathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders End stage renal disease	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.17% 7/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Haematinuria	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Haematuria	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Hydronephrosis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Hypertensive nephropathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Micturition disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Nephrolithiasis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Nephropathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Oliguria	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Postrenal failure	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal arteriosclerosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal artery stenosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal artery thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal colic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal cyst haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal failure	0.76% 31/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.61% 25/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal impairment	0.71% 29/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.61% 25/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary tract obstruction	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Renal infarct	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Ureterolithiasis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urethral stenosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Renal and urinary disorders Urinary retention	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Epididymal cyst	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Reproductive system and breast disorders Spermatocele	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.24% 10/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.24% 10/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.44% 18/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 20/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Aspiration	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Asthma-chronic obstructive pulmonary disease overlap syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchial disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchopneumopathy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.93% 38/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.5% 63/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Chronic respiratory disease	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cystic lung disease	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.76% 31/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.68% 28/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Idiopathic pulmonary fibrosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Paranasal cyst	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.34% 14/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.27% 11/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary artery thrombosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.32% 13/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.49% 20/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.29% 12/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.34% 14/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary vascular disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.44% 18/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.54% 22/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Tracheal stenosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Tracheomalacia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Blister	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermal cyst	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis exfoliative	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis exfoliative generalised	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Diabetic foot	0.15% 6/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Diabetic ulcer	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hair growth abnormal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Peau d'orange	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pemphigoid	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Psoriasis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin erosion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin necrosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin ulcer	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Stasis dermatitis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Toxic skin eruption	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Social circumstances Physical assault	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Social circumstances Victim of homicide	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Appendicectomy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Arrhythmia prophylaxis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Bladder catheter replacement	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Cardiac pacemaker replacement	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Cardiac resynchronisation therapy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Coronary angioplasty	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Coronary artery bypass	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Coronary revascularisation	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Heart transplant	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Hernia diaphragmatic repair	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Hip arthroplasty	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Hospitalisation	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Implantable defibrillator insertion	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Implantable defibrillator removal	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Inguinal hernia repair	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Knee arthroplasty	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Percutaneous coronary intervention	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Preoperative care	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Toe amputation	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Surgical and medical procedures Transurethral prostatectomy	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic aneurysm	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic aneurysm rupture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic dissection	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic dissection rupture	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic rupture	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Aortic stenosis	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arterial disorder	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arterial haemorrhage	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arterial occlusive disease	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arterial perforation	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arterial stenosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Arteriosclerosis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Axillary vein thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Brachiocephalic vein thrombosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Deep vein thrombosis	0.17% 7/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Diabetic macroangiopathy	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Distributive shock	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Dry gangrene	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Embolism arterial	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Extremity necrosis	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Haematoma	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Haemodynamic instability	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	0.24% 10/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertensive crisis	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.07% 3/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertensive emergency	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertensive urgency	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypoperfusion	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	0.90% 37/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	1.2% 49/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypovolaemic shock	0.10% 4/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.12% 5/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Iliac artery stenosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Infarction	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Ischaemia	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Jugular vein thrombosis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Leriche syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Malignant hypertension	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Orthostatic hypertension	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Orthostatic hypotension	0.27% 11/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.29% 12/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Pelvic venous thrombosis	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral arterial occlusive disease	0.44% 18/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.41% 17/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral artery occlusion	0.12% 5/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral artery stenosis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.05% 2/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral artery thrombosis	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.15% 6/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral ischaemia	0.34% 14/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.22% 9/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral vascular disorder	0.07% 3/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Peripheral venous disease	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Phlebitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Post thrombotic syndrome	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Shock	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Shock haemorrhagic	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Thrombophlebitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Thrombophlebitis superficial	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Varicose vein ruptured	0.02% 1/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.00% 0/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Vasculitis	0.00% 0/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.02% 1/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Venous thrombosis limb	0.05% 2/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	0.10% 4/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Other adverse events

Measure	Placebo n=4101 participants at risk Participants received matching placebo tablets (BID).	Omecamtiv Mecarbil n=4110 participants at risk Participants received oral omecamtiv mecarbil BID. The starting dose was 25 mg; the dose may have been adjusted at week 4 to 37.5 or 50 mg based on the predose plasma concentration measured at week 2.
Cardiac disorders Cardiac failure	7.1% 291/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.5% 268/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	5.2% 213/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.9% 202/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	4.5% 183/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	5.6% 232/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.3% 258/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.1% 249/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypertension	5.4% 222/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	4.6% 190/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.
Vascular disorders Hypotension	5.9% 242/4101 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.	6.7% 276/4110 • All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months. All-cause mortality is reported for all participants randomized in the study, excluding 24 participants due to GCP violations. All-cause mortality includes all deaths that occurred during the study including any that occurred after the efficacy analysis cut-off date. Serious adverse events and other adverse events are reported for all participants who received at least one dose of study drug.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Email: medinfo@amgen.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
• Publication restrictions are in place

Restriction type: OTHER