Trial Outcomes & Findings for Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide) (NCT NCT01147250)

NCT ID: NCT01147250

Last Updated: 2016-12-20

Results Overview

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 6068 participants
• Primary outcome timeframe: From randomization up to the end of study (median follow-up of 25 months)
• Results posted on: 2016-12-20

Participant Flow

The study was conducted at 829 centers in 49 countries. A total of 7719 participants were screened between June 24, 2010 and July 24, 2013. 1651 of whom were screen failures. Screen failures were mainly due to exclusion criteria met.

7627 participants underwent 1 week placebo run-in period. 1559 were run-in failures due to exclusion criteria met. 6068 participants were randomized 1:1 to lixisenatide and placebo arms in double-blind treatment period. Duration of study was event driven until approximately 844 positively adjudicated primary cardiovascular (CV) outcome events.

Participant milestones

Measure	Placebo Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).	Lixisenatide Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
Overall Study STARTED	3034	3034
Overall Study Treated	3032	3031
Overall Study COMPLETED	2924	2929
Overall Study NOT COMPLETED	110	105

Reasons for withdrawal

Measure	Placebo Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).	Lixisenatide Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
Overall Study Lost to Follow-up	14	11
Overall Study Withdrawal by Subject	83	88
Overall Study Site termination by sponsor	13	5
Overall Study Other than specified	0	1

Baseline Characteristics

Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)

Baseline characteristics by cohort

Measure	Placebo n=3034 Participants Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).	Lixisenatide n=3034 Participants Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).	Total n=6068 Participants Total of all reporting groups
Age, Continuous	60.6 years STANDARD_DEVIATION 9.6 • n=5 Participants	59.9 years STANDARD_DEVIATION 9.7 • n=7 Participants	60.3 years STANDARD_DEVIATION 9.7 • n=5 Participants
Gender Female	938 Participants n=5 Participants	923 Participants n=7 Participants	1861 Participants n=5 Participants
Gender Male	2096 Participants n=5 Participants	2111 Participants n=7 Participants	4207 Participants n=5 Participants
Race Caucasian/White	2318 participants n=5 Participants	2258 participants n=7 Participants	4576 participants n=5 Participants
Race Black	103 participants n=5 Participants	118 participants n=7 Participants	221 participants n=5 Participants
Race Asian/Oriental	367 participants n=5 Participants	404 participants n=7 Participants	771 participants n=5 Participants
Race Other	246 participants n=5 Participants	254 participants n=7 Participants	500 participants n=5 Participants
Ethnicity Hispanic	903 participants n=5 Participants	865 participants n=7 Participants	1768 participants n=5 Participants
Ethnicity Not Hispanic	2131 participants n=5 Participants	2169 participants n=7 Participants	4300 participants n=5 Participants
Qualifying Acute Coronary Syndrome (ACS) event ST-segment elevation myocardial infarction (MI)	1317 participants n=5 Participants	1349 participants n=7 Participants	2666 participants n=5 Participants
Qualifying Acute Coronary Syndrome (ACS) event Non ST-segment elevation MI	1183 participants n=5 Participants	1165 participants n=7 Participants	2348 participants n=5 Participants
Qualifying Acute Coronary Syndrome (ACS) event Unstable angina	528 participants n=5 Participants	514 participants n=7 Participants	1042 participants n=5 Participants
Qualifying Acute Coronary Syndrome (ACS) event Unclassified	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Qualifying Acute Coronary Syndrome (ACS) event Not qualifying ACS event	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Body Mass Index (BMI)	30.2 kg/m^2 STANDARD_DEVIATION 5.79 • n=5 Participants	30.12 kg/m^2 STANDARD_DEVIATION 5.6 • n=7 Participants	30.16 kg/m^2 STANDARD_DEVIATION 5.69 • n=5 Participants
Body Weight	85.06 kg STANDARD_DEVIATION 19.64 • n=5 Participants	84.64 kg STANDARD_DEVIATION 19.21 • n=7 Participants	84.85 kg STANDARD_DEVIATION 19.43 • n=5 Participants
Glycosylated Hemoglobin (HbA1c)	7.64 Percentage of HbA1c STANDARD_DEVIATION 1.28 • n=5 Participants	7.72 Percentage of HbA1c STANDARD_DEVIATION 1.32 • n=7 Participants	7.68 Percentage of HbA1c STANDARD_DEVIATION 1.30 • n=5 Participants
Duration of Diabetes	9.38 years STANDARD_DEVIATION 8.32 • n=5 Participants	9.2 years STANDARD_DEVIATION 8.19 • n=7 Participants	9.29 years STANDARD_DEVIATION 8.25 • n=5 Participants

PRIMARY outcome

Timeframe: From randomization up to the end of study (median follow-up of 25 months)

Population: Intent-to-treat (ITT) population defined as all randomized participants analyzed according to the treatment group allocated at randomization.

Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict the onset of primary CV endpoint over time. Number of observed participants with endpoint events were reported. A CV event adjudication committee (CAC) reviewed and adjudicated, in a blinded fashion, all potential events.

Outcome measures

Measure	Placebo n=3034 Participants Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).	Lixisenatide n=3034 Participants Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
Time to First Occurence of Primary CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke or Hospitalization for Unstable Angina	399 participants	406 participants

SECONDARY outcome

Timeframe: From randomization up to the end of study (median follow-up of 25 months)

Population: ITT population.

All CV events were positively adjudicated by the CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure. Number of observed participants with endpoint events were reported.

Outcome measures

Measure	Placebo n=3034 Participants Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).	Lixisenatide n=3034 Participants Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina or Hospitalization For Heart Failure	469 participants	456 participants

SECONDARY outcome

Timeframe: From randomization up to the end of study (median follow-up of 25 months)

Population: ITT population.

All CV events were positively adjudicated by CAC, used in the analysis of the composite CV endpoint comprised of CV death, non-fatal MI, non-fatal stroke, hospitalization for unstable angina, hospitalization for heart failure, or coronary revascularization procedure. Number of observed participants with endpoint events were reported.

Outcome measures

Measure	Placebo n=3034 Participants Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).	Lixisenatide n=3034 Participants Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
Time to First Occurence of CV Event: CV Death, Non-Fatal MI, Non-Fatal Stroke, Hospitalization for Unstable Angina, Hospitalization For Heart Failure or Coronary Revascularization Procedure	659 participants	661 participants

SECONDARY outcome

Timeframe: Baseline to Week 108 (LOCF)

Population: ITT population. Here, number of participants analyzed = participants with baseline and at least one post-baseline UACR value. Missing data was imputed using last observation carried forward (LOCF) using the last available post-baseline UACR before Week 108 as the value at Week 108, regardless of treatment discontinuation or not.

Presence of albumin in urine is a marker of nephropathy, an important microvascular complication of diabetes. UACR was defined as the ratio: mg of albumin per gram of creatinine. UACR data were log transformed before the analysis. Calculation was based on geometric mean.

Outcome measures

Measure	Placebo n=2830 Participants Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).	Lixisenatide n=2803 Participants Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
Percent Change From Baseline in the Urinary Albumin/Creatinine Ratio (UACR) at Week 108	34.21 percent change Standard Error 3.09	24.17 percent change Standard Error 2.84

Adverse Events

Placebo

Serious events: 669 serious events

Other events: 1270 other events

Deaths: 0 deaths

Lixisenatide

Serious events: 625 serious events

Other events: 1597 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=3032 participants at risk Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)	Lixisenatide n=3031 participants at risk Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)
Skin and subcutaneous tissue disorders Diabetic foot	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.26% 8/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Skin and subcutaneous tissue disorders Skin ulcer	0.33% 10/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Skin and subcutaneous tissue disorders Swelling face	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Skin and subcutaneous tissue disorders Eczema	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Skin and subcutaneous tissue disorders Psoriasis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Back pain	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Urosepsis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Wound infection	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pneumonia	1.7% 51/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	1.2% 36/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Urinary tract infection	0.63% 19/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.59% 18/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Cellulitis	0.59% 18/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.56% 17/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Gastroenteritis	0.30% 9/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.43% 13/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Sepsis	0.33% 10/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.26% 8/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Bronchopneumonia	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.20% 6/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Respiratory tract infection	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.20% 6/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Bronchitis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Osteomyelitis	0.30% 9/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Anal abscess	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Appendicitis	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Diverticulitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Erysipelas	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Lower respiratory tract infection	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Post procedural infection	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Postoperative wound infection	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pyelonephritis	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Upper respiratory tract infection	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Abdominal sepsis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Diabetic foot infection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Empyema	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Gangrene	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Gastroenteritis viral	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Infected skin ulcer	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Lobar pneumonia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pyelonephritis chronic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Septic shock	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Tooth abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Arthritis infective	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Bacteraemia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Bone abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Bronchitis viral	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Chronic sinusitis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Clostridium difficile colitis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Colonic abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Device related infection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Diarrhoea infectious	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Gallbladder abscess	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Gastritis viral	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Gastroenteritis clostridial	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Gastrointestinal infection	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Groin abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations H1N1 influenza	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Helicobacter gastritis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Infected bites	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Influenza	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Lung infection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Mediastinitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Meningitis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Mycobacterial infection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Nail bed infection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Osteomyelitis fungal	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Paraspinal abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Paronychia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Peritonitis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pilonidal cyst	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pneumonia bacterial	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pulmonary tuberculosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Puncture site abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pyelonephritis acute	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Renal abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Scrotal abscess	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Soft tissue infection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Staphylococcal infection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Subcutaneous abscess	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Toxoplasmosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Viral infection	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Abdominal abscess	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Abdominal wall infection	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Abscess limb	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Multiple sclerosis relapse	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Amoebic dysentery	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Appendicitis perforated	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Bacterial pyelonephritis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Bronchitis bacterial	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Burn infection	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Carbuncle	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Cat scratch disease	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Chronic hepatitis B	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Chronic hepatitis C	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Dengue fever	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Endocarditis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Haematoma infection	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Klebsiella sepsis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Liver abscess	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Localised infection	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Nasopharyngitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Osteomyelitis acute	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Osteomyelitis chronic	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Otitis media chronic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pleurisy viral	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Psoas abscess	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Pulmonary sepsis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Staphylococcal osteomyelitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Subdiaphragmatic abscess	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Tick-borne fever	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Infections and infestations Viral corneal ulcer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.33% 10/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.20% 6/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain neoplasm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign renal neoplasm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign salivary gland neoplasm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign small intestinal neoplasm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer stage IV	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Glioblastoma multiforme	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Iris melanoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lip squamous cell carcinoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to liver	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to pancreas	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic pain	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage III	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian epithelial cancer	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Papillary thyroid cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Phaeochromocytoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pharyngeal cancer	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer metastatic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer stage I	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenocarcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Retroperitoneal neoplasm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer metastatic	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenosquamous cell lung cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell unclassifiable lymphoma low grade	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast neoplasm	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Clear cell renal cell carcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon neoplasm	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibromatosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal adenoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cell carcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland neoplasm	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine adenocarcinoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testicular neoplasm	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Anaemia	0.30% 9/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.26% 8/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Haemorrhagic anaemia	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Increased tendency to bruise	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Iron deficiency anaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Pernicious anaemia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Nephrogenic anaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Normochromic normocytic anaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Blood and lymphatic system disorders Thrombocytopenia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Immune system disorders Anaphylactic shock	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Immune system disorders Drug hypersensitivity	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Immune system disorders Anaphylactic reaction	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Endocrine disorders Goitre	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Endocrine disorders Hyperparathyroidism	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Endocrine disorders Hyperthyroidism	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.59% 18/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.26% 8/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hyperkalaemia	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hypoglycaemia	0.33% 10/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hyponatraemia	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hyperglycaemia	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Dehydration	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hypokalaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Electrolyte imbalance	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hypovolaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Diabetic metabolic decompensation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Gout	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hypocalcaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Malnutrition	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Obesity	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Adjustment disorder	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Alcohol abuse	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Anxiety	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Completed suicide	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Confusional state	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Depression	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Mania	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Psychogenic seizure	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Suicidal ideation	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Psychiatric disorders Conversion disorder	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Syncope	0.53% 16/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.53% 16/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Presyncope	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Carotid artery stenosis	0.20% 6/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Headache	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Hypoaesthesia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Hypoglycaemic unconsciousness	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Migraine	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Brain injury	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Carotid artery dissection	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Carotid artery occlusion	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Cerebral haemorrhage	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Cervical radiculopathy	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Diabetic neuropathy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Dizziness	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Facial nerve disorder	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Facial paresis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Hypoxic-ischaemic encephalopathy	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Optic neuritis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Paraplegia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Pyramidal tract syndrome	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Radial nerve palsy	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Radicular pain	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Radiculitis lumbosacral	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Transient ischaemic attack	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders VIIth nerve paralysis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Amyotrophic lateral sclerosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Aphasia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Carpal tunnel syndrome	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Cerebral ischaemia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Cognitive disorder	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Convulsion	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Depressed level of consciousness	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Epilepsy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Essential tremor	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Hemiparesis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Intracranial haematoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Loss of consciousness	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Lumbar radiculopathy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Morton's neuralgia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Neuropathy peripheral	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Peripheral sensorimotor neuropathy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Psychomotor hyperactivity	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Sciatica	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Trigeminal neuralgia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders VIth nerve paralysis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Cataract	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Cataract nuclear	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Diabetic retinal oedema	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Glaucoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Ophthalmoplegia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Vitreous haemorrhage	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Amaurosis fugax	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Angle closure glaucoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Arteriosclerotic retinopathy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Blindness unilateral	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Diabetic eye disease	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Open angle glaucoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Retinal detachment	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Eye disorders Uveitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Ear and labyrinth disorders Vertigo positional	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Ear and labyrinth disorders Vertigo	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Ear and labyrinth disorders Vertigo labyrinthine	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Angina pectoris	0.76% 23/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.76% 23/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Atrial fibrillation	0.99% 30/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.76% 23/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Ventricular tachycardia	0.26% 8/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.30% 9/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Coronary artery disease	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Atrial flutter	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Arrhythmia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Atrioventricular block	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Atrioventricular block complete	0.26% 8/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Bradycardia	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Cardiac arrest	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Myocarditis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Ventricular extrasystoles	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Atrioventricular block first degree	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Atrioventricular block second degree	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Bifascicular block	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Cardio-respiratory arrest	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Hypertensive heart disease	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Intracardiac thrombus	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Mitral valve incompetence	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Myocardial ischaemia	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Palpitations	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Pericardial effusion	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Pericarditis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Sick sinus syndrome	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Supraventricular tachycardia	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Tachycardia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Arteriosclerosis coronary artery	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Atrial tachycardia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Coronary artery occlusion	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Ischaemic cardiomyopathy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Left ventricular dysfunction	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Pericardial haemorrhage	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Tachyarrhythmia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Trifascicular block	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Hypertensive crisis	0.43% 13/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.49% 15/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Deep vein thrombosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Hypertension	0.30% 9/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral arterial occlusive disease	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral artery stenosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Intermittent claudication	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Aortic stenosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Extremity necrosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Hypotension	0.20% 6/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Leriche syndrome	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Orthostatic hypotension	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral artery aneurysm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Aortic thrombosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Arterial disorder	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Arteritis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Circulatory collapse	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Diabetic vascular disorder	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Haemorrhage	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Hypertensive emergency	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral embolism	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral ischaemia	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral vascular disorder	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Shock haemorrhagic	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Vascular occlusion	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Accelerated hypertension	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Aortic dissection	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Arterial occlusive disease	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Arteriosclerosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Blood pressure inadequately controlled	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Embolism	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Essential hypertension	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Femoral artery aneurysm	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Granulomatosis with polyangiitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Hypovolaemic shock	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral artery thrombosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Peripheral venous disease	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Vascular stenosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Vasculitis necrotising	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Venous thrombosis limb	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.46% 14/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.49% 15/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.23% 7/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.20% 6/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Asthma	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.26% 8/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Laryngeal stenosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Nasal polyps	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pharyngeal mass	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Respiratory tract haemorrhage	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Vocal cord disorder	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Asthmatic crisis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Obstructive airways disorder	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pickwickian syndrome	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pleurisy	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Pulmonary toxicity	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Respiratory acidosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastritis	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.23% 7/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Inguinal hernia	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Duodenal ulcer	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.13% 4/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Diarrhoea	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal pain	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal pain upper	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Epigastric discomfort	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastric ulcer	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastric ulcer haemorrhage	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.20% 6/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Ileus	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Large intestine polyp	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Pancreatitis	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Umbilical hernia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Vomiting	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal adhesions	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal rigidity	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal wall haemorrhage	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Chronic gastritis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Diabetic gastroparesis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Diverticular perforation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Dyspepsia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Dysphagia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Faecal vomiting	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastroduodenitis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Intestinal haemorrhage	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Large intestine perforation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Melaena	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Oesophageal ulcer	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Oesophagitis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Pancreatitis chronic	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Small intestinal ulcer haemorrhage	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Umbilical hernia, obstructive	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal distension	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal hernia	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Abdominal incarcerated hernia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Anal fistula	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Colitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Constipation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Crohn's disease	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Diverticulum	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Duodenitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Food poisoning	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastric disorder	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastric polyps	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastritis erosive	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastritis haemorrhagic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastroduodenitis haemorrhagic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Gastrointestinal disorder	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Haematemesis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Haemorrhoids	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Impaired gastric emptying	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Intestinal obstruction	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Nausea	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Obstruction gastric	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Pancreatitis acute	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Peritoneal haemorrhage	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Cholelithiasis	0.20% 6/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.43% 13/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Cholecystitis acute	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.33% 10/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Cholecystitis	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.30% 9/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Bile duct stone	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Cholecystitis chronic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Gallbladder polyp	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Hepatic cirrhosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Hepatitis acute	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Cholangitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Cholestasis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Drug-induced liver injury	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Ischaemic hepatitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Hepatobiliary disorders Liver injury	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Arthralgia	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Fracture malunion	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Rotator cuff syndrome	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Coccydynia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Joint instability	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Lumbar spinal stenosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Osteitis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Pain in extremity	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Periarthritis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Rheumatoid arthritis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Systemic lupus erythematosus	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Bone pain	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Dupuytren's contracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Fasciitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Foot deformity	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Myalgia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Pain in jaw	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Musculoskeletal and connective tissue disorders Trigger finger	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Renal failure acute	0.66% 20/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.66% 20/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Nephrolithiasis	0.26% 8/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.23% 7/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Renal failure	0.16% 5/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.20% 6/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Renal failure chronic	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.20% 6/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Calculus urinary	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Haematuria	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Calculus bladder	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Calculus ureteric	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Hydronephrosis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Nephropathy toxic	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Renal artery stenosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Renal colic	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Renal impairment	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Urethral meatus stenosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Nephropathy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Urinary bladder haemorrhage	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Renal and urinary disorders Urinary retention	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.16% 5/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Prostatitis	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Adenomyosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Metrorrhagia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Ovarian cyst ruptured	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Prostatism	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Prostatomegaly	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Vulval ulceration	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Ovarian cyst	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Reproductive system and breast disorders Uterine prolapse	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Non-cardiac chest pain	1.4% 42/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	1.5% 46/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Chest pain	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Death	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.10% 3/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Coronary artery restenosis	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Arterial restenosis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Asthenia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Gait disturbance	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Impaired healing	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Malaise	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Multi-organ failure	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Polyp	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Pyrexia	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Sudden death	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Thrombosis in device	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Chest discomfort	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Implant site extravasation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Inflammation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Local swelling	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Oedema peripheral	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Pain	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Systemic inflammatory response syndrome	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Vessel puncture site haematoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Alanine aminotransferase increased	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Blood creatinine increased	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Blood glucose fluctuation	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Blood glucose increased	0.13% 4/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Blood pressure increased	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Carbohydrate antigen 19-9 increased	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Cardiac pacemaker evaluation	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Crystal urine present	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Electrocardiogram abnormal	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Prostatic specific antigen increased	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Angiogram	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Blood glucose abnormal	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Blood sodium decreased	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Catheterisation cardiac	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Glycosylated haemoglobin increased	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Urine output decreased	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Investigations Weight decreased	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Fall	0.23% 7/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.23% 7/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Ankle fracture	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Femur fracture	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Head injury	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Toxicity to various agents	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.07% 2/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Accidental overdose	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Allergic transfusion reaction	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Brain contusion	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Chest injury	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Contusion	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Foreign body	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Gun shot wound	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Hand fracture	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Hip fracture	0.26% 8/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Humerus fracture	0.10% 3/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Incision site haematoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Joint injury	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Limb injury	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Lower limb fracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Pubis fracture	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Rib fracture	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Scar	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Sports injury	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Tibia fracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Acetabulum fracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Alcohol poisoning	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Cartilage injury	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Concussion	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Craniocerebral injury	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Fibula fracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Joint dislocation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Ligament rupture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Ligament sprain	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Medication error	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Meniscus injury	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Multiple injuries	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Post procedural discharge	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Postoperative fever	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Procedural pain	0.07% 2/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Radius fracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Scrotal haematoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Skull fracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Soft tissue injury	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Subdural haematoma	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Ulna fracture	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Injury, poisoning and procedural complications Wound haemorrhage	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Cardioplegia	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Debridement	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Hip arthroplasty	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Leg amputation	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Pleurodesis	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Toe amputation	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Cholecystectomy	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Implantable defibrillator insertion	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Intraocular lens implant	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Knee arthroplasty	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Surgical and medical procedures Peripheral artery bypass	0.03% 1/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.00% 0/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Social circumstances Joint prosthesis user	0.00% 0/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	0.03% 1/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.

Other adverse events

Measure	Placebo n=3032 participants at risk Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)	Lixisenatide n=3031 participants at risk Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)
Infections and infestations Nasopharyngitis	6.2% 188/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	6.0% 181/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Metabolism and nutrition disorders Hypoglycaemia	18.3% 554/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	20.1% 609/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Dizziness	6.3% 191/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	8.5% 259/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Nervous system disorders Headache	4.9% 148/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	6.2% 187/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Cardiac disorders Angina pectoris	6.6% 200/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	5.8% 177/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Vascular disorders Hypertension	5.6% 171/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	5.0% 152/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Nausea	5.9% 179/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	21.7% 659/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Vomiting	2.7% 82/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	8.5% 257/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
Gastrointestinal disorders Diarrhoea	7.5% 227/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	7.8% 237/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.
General disorders Non-cardiac chest pain	5.6% 171/3032 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.	4.5% 137/3031 • All Adverse Events (AEs) were collected from signature of the informed consent form up to study end (maximum follow-up of 52 months) regardless of seriousness or relationship to investigational medicinal product (IMP). Cardiovascular efficacy endpoint events were collected and analyzed separately within same time frame. Reported AEs are treatment emergent AEs that developed/worsened during 'on treatment period' (time from first administration of IMP up to 3 days after the last administration of IMP). Analysis was done on safety population that included all randomized participants received at least one dose of IMP.

Additional Information

Trail Transparency Team

Sanofi

Email: Contact-US@sanofi.com

Results disclosure agreements

• Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER